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Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Primary Purpose

Atrial Fibrillation, Percutaneous Coronary Intervention

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dabigatran Etexilate 110mg

Warfarin 3mg

Aspirin

Dabigatran Etexilate 150mg

Clopidogrel or Ticagrelor

Warfarin 5mg

Clopidogrel or Ticagrelor

Warfarin 1mg

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Male or female patients aged >=18 years
Patients with Non Valvular Atrial Fibrillation
Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

Patients with a mechanical or biological heart valve prosthesis
Cardiogenic shock during current hospitalisation
Stroke within 1 month prior to screening visit
Patients who have had major surgery within the month prior to screening
Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
Active liver disease

Sites / Locations

Cardiology P.C.
Verde Valley Medical Center
Cardiovascular Associates of Mesa
HonorHealth Research Institute
Arkansas Cardiology, PA
Mission Cardiovascular Research Institute
Aurora Denver Cardiology Associates, PC
University of Florida College of Medicine
Watson Clinic, LLP
Community Clinical Research Center
Midwest Cardiovascular Research and Education Foundation
Ball Memorial Hospital
Richmond Cardiology Associates Research, LLC
Cardiovascular Institute of the South
Maine Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Cape Cod Research Institute
Mid Michigan Medical Center
Covenant Medical Center, Inc.
Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center
CentraCare Heart and Vascular Center
Kansas City Veterans Administration Medical Center
Saint Anthony's Medical Center
St. Michaels Medical Center
Lourdes Cardiology Services
VA Western New York Healthcare System
Novant Health Heart and Vascular Institute
Altru Health System
Cardiovascular Research Center
Chambersburg Hospital
Pinnacle Health Harrisburg Hospital
Allegheny General Hospital
Chattanooga Heart Institute
The Jackson Clinic, PA
Vanderbilt University Medical Center
Dallas VA Medical Center
North Dallas Research Associates
Scott and White Healthcare
South Texas Cardiovascular Consultants
Wichita Falls Heart Clinic
University of Utah Health Sciences Center
Sentara Norfolk General Hospital
Bayview Physicians Services PC dba Cardiovascular Associates
Holy Family Memorial, Inc
Fundación Favaloro
Hospital Italiano de Buenos Aires
Instituto Cardiovascular de Buenos Aires
Consultorios Asociados de Endocrinología e Invest Clínica
Instituto de Cardiología de Corrientes
Sanatorio Allende
Instituto CER
Inst.Cardiovascular San Luis
Investigaciones Clinicas Tucumán
Pendlebury Research
Gosford Hospital
Royal North Shore Hospital
Wollongong Hospital
The Prince Charles Hospital
Royal Adelaide Hospital
Heartcare Victoria
The Geelong Hospital
Order Hospital Elisabethinen Linz
LKH Salzburg, Univ. Clinic
Wilhelminenspital
Aalst - HOSP Onze-Lieve-Vrouw
Bonheiden - HOSP Imelda
Brussels-UNIV Brugmann -Horta
Brussels - UNIV UZ Brussel
AZ Sint-Lucas - Campus Sint Lucas
Charleroi - HOSP St-Joseph
Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim
Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)
Tienen - PRAC De Wolf, Axel
Brussels - HOSP Europe (Ste-Elisabeth)
Hospital Santa Isabel
Irmandade da Santa Casa de Misericordia de Curitiba
Instituto de Cardiologia Rio Grande do Sul
Hospital de Base - Fac Med de Sao Jose do Rio Preto
Instituto Dante Pazzanese de Cardiologia
Hospital Sao Paulo - UNIFESP
INCOR e Hospital das Clínicas da Universidade de São Paulo
Eurolatino pesquisas Médicas Ltda
MHAT "Deva Maria", Dept. of Cardiology, Burgas
SHAT in Cardiology EAD, Pleven
MHAT"Sv.Georgi",Cardi.Clin.
MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski
City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
Calgary Heart Centre
St. Boniface General Hospital
Hamilton General Hospital
Kawartha Cardiology Clinical Trials
Dr. R. Labonte Prof. Med. Corp
Thunder Bay Regional Health Science Centre
Sunnybrook Health Sciences Centre
St. Michael's Hospital
Royal Victoria Hospital
CHUS Fleurimont
IUCPQ (Laval University)
Hospital San Juan de Dios
Centro de Estudios Clinicos Barros Luco
Hospital Las Higueras
CECMI Ltda
Fundación Clínica Abood Shaio
Fundación Santa Fe de Bogotá
Centro Médico Imbanaco de Cali S.A.
Fundación Valle de Lili
Fundación Cardiovascular de Colombia
Hospital Pablo Tobón Uribe
Clincal Hospital Centre Rijeka
Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb
University hospital center Zagreb
University Hospital Dubrava
Amkardia, s.r.o. Brno
Hospital Jihlava
Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary
University Hospital Olomouc
Municipal Hospital Ostrava
Institute for Clinical and Experimental Medicine
General Faculty Hospital, Prague
University Hospital Motol
Hospital Slany, Internal Department
Hospitals of Pardubice Region, Internal Department, Svitavy
Masaryk Hospital, Usti nad Labem
Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad
Aarhus Universitetshospital
HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus
StudyCor Oy
Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola
TYKS
HOP Ambroise Paré
HOP de la Cavale Blanche
HOP Gabriel-Montpied
HOP CHU de Grenoble
HOP St Joseph
CLI du Pont de Chaume
HOP Arnaud de Villeneuve
HOP Pasteur
HOP Salpêtrière, Cardio, Paris
HOP Lariboisière
CLI Saint-Hilaire
HOP Rangueil
SLK-Kliniken Heilbronn GmbH
Kerckhoff-Klinik, Bad Nauheim
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
CIMS Studienzentrum Bamberg GmbH
Vivantes Netzwerk für Gesundheit GmbH
Charité - Universitätsmedizin Berlin
Vivantes Netzwerk für Gesundheit GmbH
Charité - Universitätsmedizin Berlin
Klinikum Bielefeld gGmbH
St. Josef- und St. Elisabeth-Hospital gGmbH
Universitätsklinikum Bonn AöR
Allgemeines Krankenhaus, Celle
Klinikum Coburg gGmbH
Helios Amper-Klinikum Dachau
St. Johannes Hospital Dortmund
Städtisches Klinikum Dresden
Praxisklinik Herz und Gefäße
Evangelisches Krankenhaus Düsseldorf
Agaplesion Markus Krankenhaus
Universitätsklinikum Frankfurt
Städtisches Klinikum, Fulda
Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem
Universitätsmedizin Göttingen, Georg-August-Universität
Universitätsklinikum Hamburg-Eppendorf
Cardiologicum Hamburg
HPK-Heidelberger Praxisklinik
Westküstenkliniken Brunsbüttel und Heide gGmbH
Universitätsklinikum des Saarlandes
Universitätsklinikum Jena
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Asklepios Klinik Langen-Seligenstadt GmbH
Herzzentrum Leipzig GmbH
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid
Universitätsklinikum Magdeburg AöR
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Universitätsklinikum Mannheim GmbH
Carl-von-Basedow Klinikum Saalekreis gGmgH
Klinikum der Universität München - Campus Großhadern
Städtisches Klinikum München GmbH
Städtisches Klinikum München GmbH
Universitätsklinikum Münster
St. Vincenz-Krankenhaus GmbH
Sana-Klinikum Remscheid GmbH
Universitätsmedizin Rostock
Robert-Bosch-Krankenhaus GmbH
Universitätsklinikum Tübingen
Universitätsklinikum Ulm
Marien-Hospital-Wesel gGmbH
Helios Universitätsklinikum Wuppertal
University Hospital of Alexandroupolis
Hippokration Hospital, Univ Clinic of Cardiology
General Hospital of Athens "Alexandra"
General Hospital of Athens Konstantopoulio-Agia Olga
General Hospital of Attica "Sismanoglio - Amalia Fleming"
General Hospital of Chios, Department of Cardiology
University General Hospital of Heraklion
Univ. Gen. Hosp. of Ioannina
University Hospital of Patras
University Hospital of Thessaloniki AHEPA
Prince of Wales Hosp, Dept of Med & Therapeutics
Princess Margaret Hospital
Queen Elizabeth Hospital
Queen Mary Hospital
Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest
Semmelweis University
Milit.Hosp.-State Health Cent.
University Debrecen Hospital
Bacs-Kiskun Megyei Onkormanyzat Hospital
University of Pecs, Invasive Cardiology
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology
Care Institute Of Medical Sciences
Medanta- The Medicity
Nizam's Institute of Medical Sciences
B and M Patel Cardiac Centre, Shree Krishna Hospital,
Shri Krishna Hrudayalaya and Critical Care
Vijan Cardiac and Critical Care Centre
Fortis Escorts Heart Institute
Byramjee Jeejeebhoy Medical College
King George's Hospital,
Mater Misericordiae University Hospital
St James's Hospital
Beaumont Hospital
University Hospital Galway
Hillel Yaffe Medical Center, Hadera
Rambam Medical Center
Wolfson Medical Center
Shaare Zedek Medical Center, Jerusalem 91031
West.Galilee Med.Cent.Naharia
Rabin Medical Center Beilinson
Ospedale San Donato di Arezzo
ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
Fond. Poliambulanza Istituto
A.O.U. Policlinico Vittorio Emanuele
Osp. Clin. SS. Anunziata
Ospedale "Fabrizio Spaziani"
Ospedale della Misericordia
Azienda Ospedaliera Vito Fazzi
Osp. Pediatrico Aprano Pasquinucci
Ospedale Cardarelli
Pol. Universitario Tor Vergata
Policlinico Gemelli
Presidio Ospedaliero di Saronno
Ospedale Bolognini
Ospedale Molinette, AO Città della Salute e della
Japanese Red Cross Nagoya Daini Hospital
Hirosaki University Hospital
Chiba University Hospital
Kokura Memorial Hospital
Fukuoka-Higashi Med. Ctr. Fukuoka, CV
Shin Koga Hospital
Gumma Prefectural Cardiovascular Center
National Hospital Organization Takasaki General Medical Center
Fukuyama Cardiovascular Hospital
Tokeidai Memorial Hospital
National Hospital Organization Hokkaido Medical Center
Hyogo Brain and Heart Center
The Veritas Hospital
Kobe University Hospital
Takahashi Hospital
National Hospital Organization Kanazawa Medical Center
Iwate Medical University Hospital
Kagawa Prefectural Central Hospital
Shonan Fujisawa Tokushukai Hospital
Kitasato University Hospital
Yokohama City Minato Red Cross Hospital
Kyoto University Hospital
Miyazaki Medical Association Hospital
Sakurabashi Watanabe Hospital
Osaka City Hospital Organization Osaka City General Hospital
Sayama General Clinic
National Hospital Organization Saitama National Hospital
Kusatsu General Hospital
Omihachiman Community Medical Center
Tokushima Red Cross Hospital
Nishiarai Heart Center Hospital
Nippon Medical School Hospital
Minamino Heart Clinic
Teikyo University Hospital
Nihon University Itabashi Hospital
Itabashi Chuo Medical Center
Global Health and Medicine Ctr
Tokyo Women's Medical University Hospital
Inje University Haeundae Paik Hospital
Kyungpook National Univ. Hosp
Yeungnam University Medical Center
Chonnam National University Hospital
Pusan National Univ. Hosp
Kyung Hee University Hospital
The Catholic University of Korea, Seoul St.Mary's Hospital
Korea University Guro Hospital
Severance Hospital
Korea University Anam Hospital
St.Carollo Hospital
Ajou University Hospital
Wonju Severance Christian Hosp
Hospital Cardiologica Aguascalientes
Instituto Nacional de Cardiologia Ignacio Chavez
H. Central Dr Ignacio M. P.
Centro Especializado en Terapia Endovascular (CETEN)
Noordwest Ziekenhuisgroep
Catharina Ziekenhuis
Scheper Ziekenhuis
Admiraal de Ruyter Ziekenhuis
UMCG
St. Antonius ziekenhuis, locatie Nieuwegein
Canisius-Wilhelmina ziekenhuis
Ziekenhuis Bernhoven Uden
Waikato Hospital
Sørlandet sykehus HF, Avd. Arendal
Oslo Universitetssykehus HF, Ullevål sykehus
Oslo Universitetssykehus HF, Rikshospitalet
Stavanger Helseforskning
Universitetssykehuset Nord-Norge, Tromsø
Univ. Clinic Hosp, Bialystok
10.Military Clin.Hospital&Polyclinic
Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk
University Clinical Center, Gdansk
Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce
Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin
Independent Public Healthcare, Dept. of Cardiology, Pulawy
Central Hospital of Medical Academy, Warsaw
Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw
John Paul II Regional Hospital, Zamosc
Hospital Garcia de Orta, EPE
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Centro Hosp. de Leiria-Pombal
CHLC, EPE - Hospital de Santa Marta
CHLO, EPE - Hospital de Santa Cruz
CHLN, EPE - Hospital de Santa Maria
CHUC,EPE - Hospital Geral dos Covões
Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul
Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk
Cent.f.Spec.Med.C.U.Cardi.Inst
State Instit.Kazan Fed.Univ.
State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan
Res.Inst.-Compl.Iss.Cardi.Dis.
Clin.Hosp.#1na S.V.Ochapovskiy
City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow
City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method
Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept
City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg
State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens
North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep
State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
National University Hospital
National Heart Center
Slov.Ins.Crdi.Dise.,Cor.C.U.
Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis
East Slovak Inst.Cardi.Disea.
Kardiocentrum Nitra,Internal Medicine Dept, Nitra
General Hospital Celje
General Hospital Izola, Cardiology Department
University Medical Center Ljubljana
Univ. Medical Center Maribor
Hospital del Mar
Hospital Vall d'Hebron
Hospital Clínic de Barcelona
Hospital de Bellvitge
Hospital Ramón y Cajal
Hospital Clínico San Carlos
Hospital La Paz
Hospital Virgen de la Victoria
Hospital de Manises
CS Parc Taulí
Hospital Clínico de Santiago
Hospital Virgen del Rocío
Hospital de Galdakao
Hospital Miguel Servet
Länssjukhuset, Gävle
Sahlgrenska Universitetssjukhuset, Östra
Länssjukhuset, Halmstad
Lasarettet, Helsingborg
Universitetssjukhuset, Linköping
Skånes universitetssjukhus, Lund
Skånes universitetssjukhus, Malmö
Danderyds Sjukhus
Chang-Hua Christian Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
E-Da Hospital
China Medical University Hospital
NCKUH
National Taiwan University Hospital
Taipe Veterans General Hospital
Chang Gung Memorial Hospital(TaoYuan)
Siriraj Hospital
Ramathibodi Hospital
Maharaj Nakorn Chiang Mai Hospital
Srinagarind Hospital
Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali
Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi
Diskapi Yildirim Beyazit EAH
Bursa Yuksek Ihtisas EAH
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul Universitesi Kardiyoloji Enstitusu
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Bagcilar Egitim ve Arastirma Hastanesi
Medipol Mega Üniversitesi Hastanesi
Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi
Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi
Kartal Kosuyolu Yuksek Ihtisas EAH
Dokuz Eylul Unv. Tip Fakultesi
Izmir Katip Celebi Univ. EAH
Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Ondokuz Mayis Universitesi Tip Fakultesi
Birmingham City Hospital
Royal Bournemouth and Christchurch Hospital
Royal Derby Hospital
Dorset County Hospital
Grantham District Hospital
Wycombe General Hospital
Glenfield Hospital
Lincoln County Hospital
Altnagelvin Area Hospital
St Bartholomew's Hospital
James Cook University Hospital
Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran Etexilate 110mg

Dabigatran Etexilate 150mg

Warfarin

Arm Description

Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Warfarin doses to maintain INR

Outcomes

Primary Outcome Measures

Time to First Adjudicated ISTH MBE or CRNMBE

Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.

Secondary Outcome Measures

Time to Adjudicated Undetermined Cause of Death

Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.

Time to Adjudicated Non-CV

Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV

Time to Adjudicated CV

Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.

Time to Adjudicated All Cause Death

Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.

Time to First Adjudicated MI

Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

Time to First Adjudicated Stroke

Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction

Time to First Adjudicated SE

Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.

Time to First Adjudicated ST

Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

Time to Composite Endpoint of Death + MI + Stroke

Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.

Time to Composite Endpoint of Death or First Thrombotic Event

Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).

Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.

Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.

Full Information

NCT ID

NCT02164864

First Posted

June 13, 2014

Last Updated

July 27, 2018

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02164864

Brief Title

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Official Title

A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 22, 2014 (Actual)

Primary Completion Date

June 5, 2017 (Actual)

Study Completion Date

June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2725 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran Etexilate 110mg

Arm Type

Experimental

Arm Description

Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Arm Title

Dabigatran Etexilate 150mg

Arm Type

Experimental

Arm Description

Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Arm Title

Warfarin

Arm Type

Active Comparator

Arm Description

Warfarin doses to maintain INR

Intervention Type

Drug

Intervention Name(s)

Dabigatran Etexilate 110mg

Intervention Description

Active treatment

Intervention Type

Drug

Intervention Name(s)

Warfarin 3mg

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Dabigatran Etexilate 150mg

Intervention Description

Active treatment

Intervention Type

Drug

Intervention Name(s)

Clopidogrel or Ticagrelor

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Clopidogrel or Ticagrelor

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Warfarin 5mg

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Clopidogrel or Ticagrelor

Intervention Description

Active comparator

Intervention Type

Drug

Intervention Name(s)

Warfarin 1mg

Intervention Description

Active comparator

Primary Outcome Measure Information:

Title

Time to First Adjudicated ISTH MBE or CRNMBE

Description

Time Frame

up to 30 months

Secondary Outcome Measure Information:

Title

Time to Adjudicated Undetermined Cause of Death

Description

Time Frame

up to 30 months

Title

Time to Adjudicated Non-CV

Description

Time Frame

up to 30 months

Title

Time to Adjudicated CV

Description

Time Frame

up to 30 months

Title

Time to Adjudicated All Cause Death

Description

Time Frame

up to 30 months

Title

Time to First Adjudicated MI

Description

Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

Time Frame

up to 30 months

Title

Time to First Adjudicated Stroke

Description

Time Frame

up to 30 months

Title

Time to First Adjudicated SE

Description

Time Frame

up to 30 months

Title

Time to First Adjudicated ST

Description

Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

Time Frame

up to 30 months

Title

Time to Composite Endpoint of Death + MI + Stroke

Description

Time Frame

up to 30 months

Title

Time to Composite Endpoint of Death or First Thrombotic Event

Description

Time Frame

up to 30 months

Title

Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

Description

Time Frame

up to 30 months

Title

Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

Description

Time Frame

up to 30 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Male or female patients aged >=18 years Patients with Non Valvular Atrial Fibrillation Patient presenting with: An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES) The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations. Exclusion criteria: Patients with a mechanical or biological heart valve prosthesis Cardiogenic shock during current hospitalisation Stroke within 1 month prior to screening visit Patients who have had major surgery within the month prior to screening Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening Active liver disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

Cardiology P.C.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Verde Valley Medical Center

City

Cottonwood

State/Province

Arizona

ZIP/Postal Code

86326

Country

United States

Facility Name

Cardiovascular Associates of Mesa

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

HonorHealth Research Institute

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Arkansas Cardiology, PA

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Mission Cardiovascular Research Institute

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Aurora Denver Cardiology Associates, PC

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

University of Florida College of Medicine

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Watson Clinic, LLP

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Community Clinical Research Center

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Midwest Cardiovascular Research and Education Foundation

City

Elkhart

State/Province

Indiana

ZIP/Postal Code

46514

Country

United States

Facility Name

Ball Memorial Hospital

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303

Country

United States

Facility Name

Richmond Cardiology Associates Research, LLC

City

Richmond

State/Province

Indiana

ZIP/Postal Code

47374

Country

United States

Facility Name

Cardiovascular Institute of the South

City

Houma

State/Province

Louisiana

ZIP/Postal Code

70360

Country

United States

Facility Name

Maine Medical Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Cape Cod Research Institute

City

Hyannis

State/Province

Massachusetts

ZIP/Postal Code

02601

Country

United States

Facility Name

Mid Michigan Medical Center

City

Midland

State/Province

Michigan

ZIP/Postal Code

48670

Country

United States

Facility Name

Covenant Medical Center, Inc.

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48602

Country

United States

Facility Name

Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

CentraCare Heart and Vascular Center

City

Saint Cloud

State/Province

Minnesota

ZIP/Postal Code

56303

Country

United States

Facility Name

Kansas City Veterans Administration Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Saint Anthony's Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

St. Michaels Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Lourdes Cardiology Services

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

VA Western New York Healthcare System

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Novant Health Heart and Vascular Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Altru Health System

City

Grand Forks

State/Province

North Dakota

ZIP/Postal Code

58201

Country

United States

Facility Name

Cardiovascular Research Center

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Chambersburg Hospital

City

Chambersburg

State/Province

Pennsylvania

ZIP/Postal Code

17201

Country

United States

Facility Name

Pinnacle Health Harrisburg Hospital

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17101

Country

United States

Facility Name

Allegheny General Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Chattanooga Heart Institute

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

The Jackson Clinic, PA

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-8802

Country

United States

Facility Name

Dallas VA Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

North Dallas Research Associates

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Scott and White Healthcare

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78665

Country

United States

Facility Name

South Texas Cardiovascular Consultants

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78201

Country

United States

Facility Name

Wichita Falls Heart Clinic

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76301

Country

United States

Facility Name

University of Utah Health Sciences Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Sentara Norfolk General Hospital

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Bayview Physicians Services PC dba Cardiovascular Associates

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Holy Family Memorial, Inc

City

Manitowoc

State/Province

Wisconsin

ZIP/Postal Code

54220

Country

United States

Facility Name

Fundación Favaloro

City

Caba

ZIP/Postal Code

C1093AAS

Country

Argentina

Facility Name

Hospital Italiano de Buenos Aires

City

Caba

ZIP/Postal Code

C1199ABB

Country

Argentina

Facility Name

Instituto Cardiovascular de Buenos Aires

City

Caba

ZIP/Postal Code

C1428DCO

Country

Argentina

Facility Name

Consultorios Asociados de Endocrinología e Invest Clínica

City

Capital Federal

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Instituto de Cardiología de Corrientes

City

Corrientes

ZIP/Postal Code

W3400AMZ

Country

Argentina

Facility Name

Sanatorio Allende

City

Córdoba

ZIP/Postal Code

X5000BFB

Country

Argentina

Facility Name

Instituto CER

City

Quilmes

ZIP/Postal Code

B1878DVB

Country

Argentina

Facility Name

Inst.Cardiovascular San Luis

City

San Luis

ZIP/Postal Code

D5702JRS

Country

Argentina

Facility Name

Investigaciones Clinicas Tucumán

City

San Miguel de Tucumán

ZIP/Postal Code

T4000ICL

Country

Argentina

Facility Name

Pendlebury Research

City

Adamstown

State/Province

New South Wales

ZIP/Postal Code

2289

Country

Australia

Facility Name

Gosford Hospital

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Royal North Shore Hospital

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Wollongong Hospital

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

The Prince Charles Hospital

City

Chermside

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Heartcare Victoria

City

Bundoora

State/Province

Victoria

ZIP/Postal Code

3083

Country

Australia

Facility Name

The Geelong Hospital

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Order Hospital Elisabethinen Linz

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

LKH Salzburg, Univ. Clinic

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Wilhelminenspital

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Aalst - HOSP Onze-Lieve-Vrouw

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Bonheiden - HOSP Imelda

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Brussels-UNIV Brugmann -Horta

City

Brussel

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Brussels - UNIV UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

AZ Sint-Lucas - Campus Sint Lucas

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Charleroi - HOSP St-Joseph

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

City

Middelheim

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Tienen - PRAC De Wolf, Axel

City

Tienen

ZIP/Postal Code

3300

Country

Belgium

Facility Name

Brussels - HOSP Europe (Ste-Elisabeth)

City

Ukkel

ZIP/Postal Code

1180

Country

Belgium

Facility Name

Hospital Santa Isabel

City

Blumenau

ZIP/Postal Code

89010-500

Country

Brazil

Facility Name

Irmandade da Santa Casa de Misericordia de Curitiba

City

Campina Grande do Sul

ZIP/Postal Code

83430-000

Country

Brazil

Facility Name

Instituto de Cardiologia Rio Grande do Sul

City

Porto Alegre

ZIP/Postal Code

90620-001

Country

Brazil

Facility Name

Hospital de Base - Fac Med de Sao Jose do Rio Preto

City

Sao Jose do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Instituto Dante Pazzanese de Cardiologia

City

Sao Paulo

ZIP/Postal Code

04012-909

Country

Brazil

Facility Name

Hospital Sao Paulo - UNIFESP

City

Sao Paulo

ZIP/Postal Code

04024-002

Country

Brazil

Facility Name

INCOR e Hospital das Clínicas da Universidade de São Paulo

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Eurolatino pesquisas Médicas Ltda

City

Uberlandia

ZIP/Postal Code

38411-186

Country

Brazil

Facility Name

MHAT "Deva Maria", Dept. of Cardiology, Burgas

City

Burgas

ZIP/Postal Code

8127

Country

Bulgaria

Facility Name

SHAT in Cardiology EAD, Pleven

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

MHAT"Sv.Georgi",Cardi.Clin.

City

Plovdiv

ZIP/Postal Code

4001

Country

Bulgaria

Facility Name

MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski

City

Sandanski

ZIP/Postal Code

2800

Country

Bulgaria

Facility Name

City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Calgary Heart Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

St. Boniface General Hospital

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 2A6

Country

Canada

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Kawartha Cardiology Clinical Trials

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 0B2

Country

Canada

Facility Name

Dr. R. Labonte Prof. Med. Corp

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 3B8

Country

Canada

Facility Name

Thunder Bay Regional Health Science Centre

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

CHUS Fleurimont

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

IUCPQ (Laval University)

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

GLV 4G5

Country

Canada

Facility Name

Hospital San Juan de Dios

City

Santiago

ZIP/Postal Code

8350488

Country

Chile

Facility Name

Centro de Estudios Clinicos Barros Luco

City

Santiago

ZIP/Postal Code

8910131

Country

Chile

Facility Name

Hospital Las Higueras

City

Talcahuano

ZIP/Postal Code

4270918

Country

Chile

Facility Name

CECMI Ltda

City

Temuco

ZIP/Postal Code

4813299

Country

Chile

Facility Name

Fundación Clínica Abood Shaio

City

Bogotá

Country

Colombia

Facility Name

Fundación Santa Fe de Bogotá

City

Bogotá

Country

Colombia

Facility Name

Centro Médico Imbanaco de Cali S.A.

City

Cali

ZIP/Postal Code

760042

Country

Colombia

Facility Name

Fundación Valle de Lili

City

Cali

Country

Colombia

Facility Name

Fundación Cardiovascular de Colombia

City

Floridablanca

ZIP/Postal Code

680004

Country

Colombia

Facility Name

Hospital Pablo Tobón Uribe

City

Medellin

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Clincal Hospital Centre Rijeka

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

University hospital center Zagreb

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

University Hospital Dubrava

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Amkardia, s.r.o. Brno

City

Brno

ZIP/Postal Code

63900

Country

Czechia

Facility Name

Hospital Jihlava

City

Jihlava

ZIP/Postal Code

586 33

Country

Czechia

Facility Name

Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

City

Karlovy Vary

ZIP/Postal Code

36001

Country

Czechia

Facility Name

University Hospital Olomouc

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Municipal Hospital Ostrava

City

Ostrava

ZIP/Postal Code

728 80

Country

Czechia

Facility Name

Institute for Clinical and Experimental Medicine

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

General Faculty Hospital, Prague

City

Praha

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

University Hospital Motol

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Hospital Slany, Internal Department

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Hospitals of Pardubice Region, Internal Department, Svitavy

City

Svitavy

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

Masaryk Hospital, Usti nad Labem

City

Usti nad Labem

ZIP/Postal Code

401 13

Country

Czechia

Facility Name

Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad

City

Usti nad Orlici

ZIP/Postal Code

562 18

Country

Czechia

Facility Name

Aarhus Universitetshospital

City

Århus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

StudyCor Oy

City

Jyväskylä

ZIP/Postal Code

42620

Country

Finland

Facility Name

Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

City

Kokkola

ZIP/Postal Code

67200

Country

Finland

Facility Name

TYKS

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

HOP Ambroise Paré

City

Boulogne-Billancourt

ZIP/Postal Code

92104

Country

France

Facility Name

HOP de la Cavale Blanche

City

Brest Cedex 2

ZIP/Postal Code

29609

Country

France

Facility Name

HOP Gabriel-Montpied

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

HOP CHU de Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

HOP St Joseph

City

Marseille

ZIP/Postal Code

13285

Country

France

Facility Name

CLI du Pont de Chaume

City

Montauban

ZIP/Postal Code

82000

Country

France

Facility Name

HOP Arnaud de Villeneuve

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

HOP Pasteur

City

Nice

ZIP/Postal Code

06002

Country

France

Facility Name

HOP Salpêtrière, Cardio, Paris

City

Paris cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

HOP Lariboisière

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

CLI Saint-Hilaire

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

HOP Rangueil

City

Toulouse

ZIP/Postal Code

31403

Country

France

Facility Name

SLK-Kliniken Heilbronn GmbH

City

Bad Friedrichshall

ZIP/Postal Code

74177

Country

Germany

Facility Name

Kerckhoff-Klinik, Bad Nauheim

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Facility Name

CIMS Studienzentrum Bamberg GmbH

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Vivantes Netzwerk für Gesundheit GmbH

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Vivantes Netzwerk für Gesundheit GmbH

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Klinikum Bielefeld gGmbH

City

Bielefeld

ZIP/Postal Code

33604

Country

Germany

Facility Name

St. Josef- und St. Elisabeth-Hospital gGmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Universitätsklinikum Bonn AöR

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Allgemeines Krankenhaus, Celle

City

Celle

ZIP/Postal Code

29223

Country

Germany

Facility Name

Klinikum Coburg gGmbH

City

Coburg

ZIP/Postal Code

96450

Country

Germany

Facility Name

Helios Amper-Klinikum Dachau

City

Dachau

ZIP/Postal Code

85221

Country

Germany

Facility Name

St. Johannes Hospital Dortmund

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

Städtisches Klinikum Dresden

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Praxisklinik Herz und Gefäße

City

Dresden

ZIP/Postal Code

01324

Country

Germany

Facility Name

Evangelisches Krankenhaus Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40217

Country

Germany

Facility Name

Agaplesion Markus Krankenhaus

City

Frankfurt

ZIP/Postal Code

60431

Country

Germany

Facility Name

Universitätsklinikum Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Städtisches Klinikum, Fulda

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem

City

Göttingen

ZIP/Postal Code

37073

Country

Germany

Facility Name

Universitätsmedizin Göttingen, Georg-August-Universität

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Cardiologicum Hamburg

City

Hamburg

ZIP/Postal Code

22041

Country

Germany

Facility Name

HPK-Heidelberger Praxisklinik

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Westküstenkliniken Brunsbüttel und Heide gGmbH

City

Heide

ZIP/Postal Code

25746

Country

Germany

Facility Name

Universitätsklinikum des Saarlandes

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Universitätsklinikum Jena

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Universitätsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Asklepios Klinik Langen-Seligenstadt GmbH

City

Langen

ZIP/Postal Code

63225

Country

Germany

Facility Name

Herzzentrum Leipzig GmbH

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Facility Name

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

City

Lüdenscheid

ZIP/Postal Code

58515

Country

Germany

Facility Name

Universitätsklinikum Magdeburg AöR

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitätsklinikum Mannheim GmbH

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Carl-von-Basedow Klinikum Saalekreis gGmgH

City

Merseburg

ZIP/Postal Code

06217

Country

Germany

Facility Name

Klinikum der Universität München - Campus Großhadern

City

München

ZIP/Postal Code

81377

Country

Germany

Facility Name

Städtisches Klinikum München GmbH

City

München

ZIP/Postal Code

81737

Country

Germany

Facility Name

Städtisches Klinikum München GmbH

City

München

ZIP/Postal Code

81925

Country

Germany

Facility Name

Universitätsklinikum Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

St. Vincenz-Krankenhaus GmbH

City

Paderborn

ZIP/Postal Code

33098

Country

Germany

Facility Name

Sana-Klinikum Remscheid GmbH

City

Remscheid

ZIP/Postal Code

42859

Country

Germany

Facility Name

Universitätsmedizin Rostock

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Robert-Bosch-Krankenhaus GmbH

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitätsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Marien-Hospital-Wesel gGmbH

City

Wesel

ZIP/Postal Code

46483

Country

Germany

Facility Name

Helios Universitätsklinikum Wuppertal

City

Wuppertal

ZIP/Postal Code

42117

Country

Germany

Facility Name

University Hospital of Alexandroupolis

City

Alexandroupoli

ZIP/Postal Code

68100

Country

Greece

Facility Name

Hippokration Hospital, Univ Clinic of Cardiology

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

General Hospital of Athens "Alexandra"

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

General Hospital of Athens Konstantopoulio-Agia Olga

City

Athens

ZIP/Postal Code

14233

Country

Greece

Facility Name

General Hospital of Attica "Sismanoglio - Amalia Fleming"

City

Athens

ZIP/Postal Code

15126

Country

Greece

Facility Name

General Hospital of Chios, Department of Cardiology

City

Chios

ZIP/Postal Code

82100

Country

Greece

Facility Name

University General Hospital of Heraklion

City

Heraklion, Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Univ. Gen. Hosp. of Ioannina

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

University Hospital of Patras

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

University Hospital of Thessaloniki AHEPA

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Prince of Wales Hosp, Dept of Med & Therapeutics

City

Hong Kong

Country

Hong Kong

Facility Name

Princess Margaret Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Elizabeth Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

Semmelweis University

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Milit.Hosp.-State Health Cent.

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

University Debrecen Hospital

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Bacs-Kiskun Megyei Onkormanyzat Hospital

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

University of Pecs, Invasive Cardiology

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Care Institute Of Medical Sciences

City

Ahmedabad

ZIP/Postal Code

380060

Country

India

Facility Name

Medanta- The Medicity

City

Gurgaon

ZIP/Postal Code

122001

Country

India

Facility Name

Nizam's Institute of Medical Sciences

City

Hyderabad

ZIP/Postal Code

500034

Country

India

Facility Name

B and M Patel Cardiac Centre, Shree Krishna Hospital,

City

Karamsad

ZIP/Postal Code

388325

Country

India

Facility Name

Shri Krishna Hrudayalaya and Critical Care

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

Vijan Cardiac and Critical Care Centre

City

Nasik

ZIP/Postal Code

422005

Country

India

Facility Name

Fortis Escorts Heart Institute

City

New Delhi

ZIP/Postal Code

110025

Country

India

Facility Name

Byramjee Jeejeebhoy Medical College

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

King George's Hospital,

City

Seemandhra

ZIP/Postal Code

530002

Country

India

Facility Name

Mater Misericordiae University Hospital

City

Dublin

ZIP/Postal Code

DUBLIN 7

Country

Ireland

Facility Name

St James's Hospital

City

Dublin

ZIP/Postal Code

DUBLIN 8

Country

Ireland

Facility Name

Beaumont Hospital

City

Dublin

ZIP/Postal Code

DUBLIN 9

Country

Ireland

Facility Name

University Hospital Galway

City

Galway

ZIP/Postal Code

GALWAY

Country

Ireland

Facility Name

Hillel Yaffe Medical Center, Hadera

City

Hadera

ZIP/Postal Code

38100

Country

Israel

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Wolfson Medical Center

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Shaare Zedek Medical Center, Jerusalem 91031

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

West.Galilee Med.Cent.Naharia

City

Naharia

ZIP/Postal Code

22100

Country

Israel

Facility Name

Rabin Medical Center Beilinson

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Ospedale San Donato di Arezzo

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Fond. Poliambulanza Istituto

City

Brescia

ZIP/Postal Code

25100

Country

Italy

Facility Name

A.O.U. Policlinico Vittorio Emanuele

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Osp. Clin. SS. Anunziata

City

Chieti

ZIP/Postal Code

66100

Country

Italy

Facility Name

Ospedale "Fabrizio Spaziani"

City

Frosinone

ZIP/Postal Code

03100

Country

Italy

Facility Name

Ospedale della Misericordia

City

Grosseto

ZIP/Postal Code

58100

Country

Italy

Facility Name

Azienda Ospedaliera Vito Fazzi

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Osp. Pediatrico Aprano Pasquinucci

City

Massa

ZIP/Postal Code

54100

Country

Italy

Facility Name

Ospedale Cardarelli

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Pol. Universitario Tor Vergata

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Policlinico Gemelli

City

Roma

ZIP/Postal Code

00195

Country

Italy

Facility Name

Presidio Ospedaliero di Saronno

City

Saronno (VA)

ZIP/Postal Code

21047

Country

Italy

Facility Name

Ospedale Bolognini

City

Seriate

ZIP/Postal Code

24068

Country

Italy

Facility Name

Ospedale Molinette, AO Città della Salute e della

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Japanese Red Cross Nagoya Daini Hospital

City

Aichi, Nagoya

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

Hirosaki University Hospital

City

Aomori, Hirosaki

ZIP/Postal Code

036-8563

Country

Japan

Facility Name

Chiba University Hospital

City

Chiba, Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Kokura Memorial Hospital

City

Fukuoka, Kitakyushu

ZIP/Postal Code

802-8555

Country

Japan

Facility Name

Fukuoka-Higashi Med. Ctr. Fukuoka, CV

City

Fukuoka, Koga

ZIP/Postal Code

811-3195

Country

Japan

Facility Name

Shin Koga Hospital

City

Fukuoka, Kurume

ZIP/Postal Code

830-8577

Country

Japan

Facility Name

Gumma Prefectural Cardiovascular Center

City

Gunma, Maebashi

ZIP/Postal Code

371-0004

Country

Japan

Facility Name

National Hospital Organization Takasaki General Medical Center

City

Gunma, Takasaki

ZIP/Postal Code

370-0829

Country

Japan

Facility Name

Fukuyama Cardiovascular Hospital

City

Hiroshima, Fukuyama

ZIP/Postal Code

720-0804

Country

Japan

Facility Name

Tokeidai Memorial Hospital

City

Hokkaido, Sapporo

ZIP/Postal Code

060-0031

Country

Japan

Facility Name

National Hospital Organization Hokkaido Medical Center

City

Hokkaido, Sapporo

ZIP/Postal Code

063-0005

Country

Japan

Facility Name

Hyogo Brain and Heart Center

City

Hyogo, Himeji

ZIP/Postal Code

670-0981

Country

Japan

Facility Name

The Veritas Hospital

City

Hyogo, Kawanishi

ZIP/Postal Code

666-0125

Country

Japan

Facility Name

Kobe University Hospital

City

Hyogo, Kobe

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Takahashi Hospital

City

Hyogo, Kobe

ZIP/Postal Code

654-0026

Country

Japan

Facility Name

National Hospital Organization Kanazawa Medical Center

City

Ishikawa, Kanazawa

ZIP/Postal Code

920-8650

Country

Japan

Facility Name

Iwate Medical University Hospital

City

Iwate, Morioka

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

Kagawa Prefectural Central Hospital

City

Kagawa, Takamatsu

ZIP/Postal Code

760-8557

Country

Japan

Facility Name

Shonan Fujisawa Tokushukai Hospital

City

Kanagawa, Fujisawa

ZIP/Postal Code

251-0041

Country

Japan

Facility Name

Kitasato University Hospital

City

Kanagawa, Sagamihara

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Yokohama City Minato Red Cross Hospital

City

Kanagawa, Yokohama

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Kyoto University Hospital

City

Kyoto, Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Miyazaki Medical Association Hospital

City

Miyazaki, Miyazaki

ZIP/Postal Code

880-0834

Country

Japan

Facility Name

Sakurabashi Watanabe Hospital

City

Osaka, Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

Osaka City Hospital Organization Osaka City General Hospital

City

Osaka, Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

Sayama General Clinic

City

Saitama, Sayama

ZIP/Postal Code

350-1305

Country

Japan

Facility Name

National Hospital Organization Saitama National Hospital

City

Saitama, Wako

ZIP/Postal Code

351-0102

Country

Japan

Facility Name

Kusatsu General Hospital

City

Shiga, Kusatsu

ZIP/Postal Code

525-8585

Country

Japan

Facility Name

Omihachiman Community Medical Center

City

Shiga, Omihachiman

ZIP/Postal Code

523-0082

Country

Japan

Facility Name

Tokushima Red Cross Hospital

City

Tokushima, Komatsushima

ZIP/Postal Code

773-8502

Country

Japan

Facility Name

Nishiarai Heart Center Hospital

City

Tokyo, Adachi-ku

ZIP/Postal Code

123-0845

Country

Japan

Facility Name

Nippon Medical School Hospital

City

Tokyo, Bunkyo-ku

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Minamino Heart Clinic

City

Tokyo, Hachioji

ZIP/Postal Code

192-0918

Country

Japan

Facility Name

Teikyo University Hospital

City

Tokyo, Itabashi-Ku

ZIP/Postal Code

173-8606

Country

Japan

Facility Name

Nihon University Itabashi Hospital

City

Tokyo, Itabashi-Ku

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Itabashi Chuo Medical Center

City

Tokyo, Itabashi-Ku

ZIP/Postal Code

174-0051

Country

Japan

Facility Name

Global Health and Medicine Ctr

City

Tokyo, Shinjuku-ku

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Tokyo Women's Medical University Hospital

City

Tokyo, Shinjuku-ku

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Inje University Haeundae Paik Hospital

City

Busan

ZIP/Postal Code

612-896

Country

Korea, Republic of

Facility Name

Kyungpook National Univ. Hosp

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

Yeungnam University Medical Center

City

Daegu

ZIP/Postal Code

705-703

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Pusan National Univ. Hosp

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Kyung Hee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St.Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

St.Carollo Hospital

City

Suncheon

ZIP/Postal Code

540-719

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Wonju Severance Christian Hosp

City

Wonju

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

Hospital Cardiologica Aguascalientes

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Instituto Nacional de Cardiologia Ignacio Chavez

City

Ciudad de Mexico

ZIP/Postal Code

14080

Country

Mexico

Facility Name

H. Central Dr Ignacio M. P.

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Centro Especializado en Terapia Endovascular (CETEN)

City

Zapopan, Jalisco

ZIP/Postal Code

45040

Country

Mexico

Facility Name

Noordwest Ziekenhuisgroep

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Catharina Ziekenhuis

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Scheper Ziekenhuis

City

Emmen

ZIP/Postal Code

7824 AA

Country

Netherlands

Facility Name

Admiraal de Ruyter Ziekenhuis

City

Goes

ZIP/Postal Code

4462 GA

Country

Netherlands

Facility Name

UMCG

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

St. Antonius ziekenhuis, locatie Nieuwegein

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Canisius-Wilhelmina ziekenhuis

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

Ziekenhuis Bernhoven Uden

City

Uden

ZIP/Postal Code

5406 PT

Country

Netherlands

Facility Name

Waikato Hospital

City

Hamilton

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Sørlandet sykehus HF, Avd. Arendal

City

Arendal

ZIP/Postal Code

N-4838

Country

Norway

Facility Name

Oslo Universitetssykehus HF, Ullevål sykehus

City

Oslo

ZIP/Postal Code

N-0407

Country

Norway

Facility Name

Oslo Universitetssykehus HF, Rikshospitalet

City

Oslo

ZIP/Postal Code

N-0424

Country

Norway

Facility Name

Stavanger Helseforskning

City

Stavanger

ZIP/Postal Code

N-4068

Country

Norway

Facility Name

Universitetssykehuset Nord-Norge, Tromsø

City

Tromsø

ZIP/Postal Code

N-9038

Country

Norway

Facility Name

Univ. Clinic Hosp, Bialystok

City

Bialystok

ZIP/Postal Code

15276

Country

Poland

Facility Name

10.Military Clin.Hospital&Polyclinic

City

Bydgoszcz

ZIP/Postal Code

85681

Country

Poland

Facility Name

Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk

City

Gdansk

ZIP/Postal Code

80215

Country

Poland

Facility Name

University Clinical Center, Gdansk

City

Gdansk

ZIP/Postal Code

80952

Country

Poland

Facility Name

Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

City

Kielce

ZIP/Postal Code

25736

Country

Poland

Facility Name

Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin

City

Lublin

ZIP/Postal Code

20954

Country

Poland

Facility Name

Independent Public Healthcare, Dept. of Cardiology, Pulawy

City

Pulawy

ZIP/Postal Code

24100

Country

Poland

Facility Name

Central Hospital of Medical Academy, Warsaw

City

Warsaw

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw

City

Wroclaw

ZIP/Postal Code

54049

Country

Poland

Facility Name

John Paul II Regional Hospital, Zamosc

City

Zamosc

ZIP/Postal Code

22400

Country

Poland

Facility Name

Hospital Garcia de Orta, EPE

City

Almada

ZIP/Postal Code

2805-267

Country

Portugal

Facility Name

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Centro Hosp. de Leiria-Pombal

City

Leiria

ZIP/Postal Code

2410-197

Country

Portugal

Facility Name

CHLC, EPE - Hospital de Santa Marta

City

Lisboa

ZIP/Postal Code

1169-024

Country

Portugal

Facility Name

CHLO, EPE - Hospital de Santa Cruz

City

Lisboa

ZIP/Postal Code

1495-005

Country

Portugal

Facility Name

CHLN, EPE - Hospital de Santa Maria

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

CHUC,EPE - Hospital Geral dos Covões

City

S. Martinho Do Bispo,Coimbra

ZIP/Postal Code

3041-801

Country

Portugal

Facility Name

Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

City

Barnaul

ZIP/Postal Code

656055

Country

Russian Federation

Facility Name

Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Cent.f.Spec.Med.C.U.Cardi.Inst

City

Ekaterinburg

ZIP/Postal Code

620144

Country

Russian Federation

Facility Name

State Instit.Kazan Fed.Univ.

City

Kazan

ZIP/Postal Code

420043

Country

Russian Federation

Facility Name

State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan

City

Kazan

ZIP/Postal Code

420103

Country

Russian Federation

Facility Name

Res.Inst.-Compl.Iss.Cardi.Dis.

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Clin.Hosp.#1na S.V.Ochapovskiy

City

Krasnodar

ZIP/Postal Code

350086

Country

Russian Federation

Facility Name

City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow

City

Moscow

ZIP/Postal Code

111 539

Country

Russian Federation

Facility Name

City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

City

Saint Petersburg

ZIP/Postal Code

199 106

Country

Russian Federation

Facility Name

State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens

City

Samara

ZIP/Postal Code

443070

Country

Russian Federation

Facility Name

North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep

City

St.Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

City

Volgograd

ZIP/Postal Code

400008

Country

Russian Federation

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

National Heart Center

City

Singapore

ZIP/Postal Code

169609

Country

Singapore

Facility Name

Slov.Ins.Crdi.Dise.,Cor.C.U.

City

Banska Bystrica

ZIP/Postal Code

97401

Country

Slovakia

Facility Name

Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis

City

Bratislava

ZIP/Postal Code

83348

Country

Slovakia

Facility Name

East Slovak Inst.Cardi.Disea.

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Kardiocentrum Nitra,Internal Medicine Dept, Nitra

City

Nitra

ZIP/Postal Code

94901

Country

Slovakia

Facility Name

General Hospital Celje

City

Celje

ZIP/Postal Code

3000

Country

Slovenia

Facility Name

General Hospital Izola, Cardiology Department

City

Izola

ZIP/Postal Code

6310

Country

Slovenia

Facility Name

University Medical Center Ljubljana

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Univ. Medical Center Maribor

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clínic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital de Bellvitge

City

L'Hospitalet Llobregat (bcn)

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Virgen de la Victoria

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital de Manises

City

Manises

ZIP/Postal Code

46940

Country

Spain

Facility Name

CS Parc Taulí

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Clínico de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Virgen del Rocío

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital de Galdakao

City

Vizcaya

ZIP/Postal Code

48960

Country

Spain

Facility Name

Hospital Miguel Servet

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Länssjukhuset, Gävle

City

Gävle

ZIP/Postal Code

801 87

Country

Sweden

Facility Name

Sahlgrenska Universitetssjukhuset, Östra

City

Göteborg

ZIP/Postal Code

416 85

Country

Sweden

Facility Name

Länssjukhuset, Halmstad

City

Halmstad

ZIP/Postal Code

301 85

Country

Sweden

Facility Name

Lasarettet, Helsingborg

City

Helsingborg

ZIP/Postal Code

251 87

Country

Sweden

Facility Name

Universitetssjukhuset, Linköping

City

Linköping

ZIP/Postal Code

581 85

Country

Sweden

Facility Name

Skånes universitetssjukhus, Lund

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Skånes universitetssjukhus, Malmö

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Danderyds Sjukhus

City

Stockholm

ZIP/Postal Code

182 88

Country

Sweden

Facility Name

Chang-Hua Christian Hospital

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

E-Da Hospital

City

Kaohsiung

ZIP/Postal Code

824

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

NCKUH

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Taipe Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital(TaoYuan)

City

Taoyuan

ZIP/Postal Code

330

Country

Taiwan

Facility Name

Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10170

Country

Thailand

Facility Name

Ramathibodi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Maharaj Nakorn Chiang Mai Hospital

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Srinagarind Hospital

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Diskapi Yildirim Beyazit EAH

City

Ankara

ZIP/Postal Code

06110

Country

Turkey

Facility Name

Bursa Yuksek Ihtisas EAH

City

Bursa

ZIP/Postal Code

16330

Country

Turkey

Facility Name

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Istanbul Universitesi Kardiyoloji Enstitusu

City

Istanbul

ZIP/Postal Code

34096

Country

Turkey

Facility Name

Istanbul Universitesi Cerrahpasa Tip Fakultesi

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Bagcilar Egitim ve Arastirma Hastanesi

City

Istanbul

ZIP/Postal Code

34200

Country

Turkey

Facility Name

Medipol Mega Üniversitesi Hastanesi

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Facility Name

Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

City

Istanbul

ZIP/Postal Code

34668

Country

Turkey

Facility Name

Kartal Kosuyolu Yuksek Ihtisas EAH

City

Istanbul

ZIP/Postal Code

34846

Country

Turkey

Facility Name

Dokuz Eylul Unv. Tip Fakultesi

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Izmir Katip Celebi Univ. EAH

City

Izmir

ZIP/Postal Code

35360

Country

Turkey

Facility Name

Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Ondokuz Mayis Universitesi Tip Fakultesi

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Birmingham City Hospital

City

Birmingham

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

Royal Bournemouth and Christchurch Hospital

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Royal Derby Hospital

City

Derby

ZIP/Postal Code

DE22 3NE

Country

United Kingdom

Facility Name

Dorset County Hospital

City

Dorchester

ZIP/Postal Code

DT1 2JY

Country

United Kingdom

Facility Name

Grantham District Hospital

City

Grantham

ZIP/Postal Code

NG31 8DG

Country

United Kingdom

Facility Name

Wycombe General Hospital

City

High Wycombe

ZIP/Postal Code

HP11 2TT

Country

United Kingdom

Facility Name

Glenfield Hospital

City

Leicester

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

Lincoln County Hospital

City

Lincoln

ZIP/Postal Code

LN2 5QY

Country

United Kingdom

Facility Name

Altnagelvin Area Hospital

City

Londonderry

ZIP/Postal Code

BT47 6SB

Country

United Kingdom

Facility Name

St Bartholomew's Hospital

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

James Cook University Hospital

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Royal Stoke University Hospital

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32562206

Citation

Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.

Results Reference

derived

PubMed Identifier

32389658

Citation

De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.

Results Reference

derived

PubMed Identifier

32252548

Citation

Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.

Results Reference

derived

PubMed Identifier

31439336

Citation

Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.

Results Reference

derived

PubMed Identifier

30015064

Citation

Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

Results Reference

derived

PubMed Identifier

28844193

Citation

Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com

Description

Related Info

Learn more about this trial

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

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