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Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation focused on measuring Nonvalvular Atrial Fibrillation, High Creatinine Clearance, Developmental Phase III, Anticoagulant Naïve

Eligibility Criteria

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

Inclusion Criteria:

  • Meets protocol-specified criteria for qualification
  • Is able to follow the protocol specified contraception methods
  • Is willing and able to comply with any restrictions related to food, drink and medications
  • Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

  • Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

    1. the safety or well-being of the participant or study staff
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
    3. the analysis of results

Sites / Locations

  • O L V Ziekenhuis
  • ZNA Middelheim
  • AZ Sint-Jan Brugge
  • C H U Brugmann - Site Victor Horta
  • Jessa Ziekenhuis - Campus Virga Jesse
  • St-Franciskus Ziekenhuis
  • Universitairsitaire Ziekenhuizen Leuven
  • C H R de la Citadelle
  • AZ Sint-Maarten
  • AZ Turnhout - Campus Sint-Elisabeth
  • MHAT 'Sveta Ekaterina' EOOD
  • MHAT Dr Tota Venkova AD
  • Medical Center Haskovo EOOD
  • MHAT-Haskovo AD
  • MHAT - Pazardzhik AD
  • MHAT Sv Pantaleymon - Pleven OOD
  • SHATC Pleven EAD
  • UMHAT 'Dr Georgi Stranski' EAD
  • UMHAT Sv Georgi EAD
  • MHAT-Plovdiv AD
  • Second MHAT - Sofia AD
  • Fifth MHAT - Sofia EAD
  • NMTH Tsar Boris III
  • MHAT - National Heart Hospital EAD
  • UMHAT Alexandrovska EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL' EAD
  • Fourth MHAT - Sofia EAD
  • UMHAT 'Sveta Anna' AD
  • SHATC Cardiolife OOD
  • General Hospital Dubrovnik
  • General Hospital Dr Tomislav Bardek
  • Special Hospital for medical rehabilitation
  • Clinical Hospital Centre Rijeka
  • General Hospital Dr Josip Bencevic
  • General Hospital Varazdin
  • General Hospital Zadar
  • Clinical Hospital Center Sestre Milosrdnice
  • Clinical Hospital Dubrava
  • Clinical Hospital Sveti Duh
  • University Hospital center Zagreb (2108)
  • University Hospital center Zagreb (2110)
  • Innera s r o
  • Poliklinika Humanitas
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u sv. Anny v Brne
  • Edumed s.r.o
  • Nemocnice Havlickuv Brod, p.o.
  • Kardio-Pisova, s.r.o.
  • Oblastni nemocnice Kolin, a.s.
  • Centrum pro choroby srdce a cev
  • Kromerizska nemocnice, a.s.
  • InterKardioML s r o
  • PV - kardiologie s.r.o.
  • Corintez s.r.o
  • Ordince pro choroby srdce a cev
  • AVICENA -KARDIOLOGIE, INTERNA s.r.o.
  • Nemocnice na Frantisku
  • Fakultni nemocnice v Motole
  • Kardio-Pisova sro
  • Poliklinika RAVAK
  • Oblastni nemocnice Pribram, a.s.
  • Nemocnice Slany
  • Poliklinika Masarykuv Dum, s.r.o.
  • Clinical Trials Services s.r.o
  • Krajska nemocnice T Bati a s
  • Amager Hospital
  • Bispebjeg og Fredeiksberg Hospital
  • Gentofte Hospital
  • Herlev Hospital
  • Holbæk Sygehus
  • Hvidovre Hospital
  • Rigshospitalet
  • Nykøbing F Sygehus
  • Slagelse Sygehus
  • Regionshospitalet Viborg
  • East Tallinn Central Hospital
  • Dr Arvo Rosenthal LLC
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital
  • Principal SMO Kft
  • Belgyogyaszati es Kardiologiai Maganrendelo
  • Grof Tisza Istvan Korhaz
  • Budapesti Szent Ferenc Korhaz
  • Budai Irgalmasrendi Korhaz
  • Szent Margit Korhaz
  • Obudai Egeszsegugyi Centrum Kft
  • Bajcsy-Zsilinszky Korhaz es Rendelointezet
  • Semmelweis Egyetem
  • Semmelweis Egyetem
  • Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
  • Uzsoki Utcai Korhaz
  • Debreceni Egyetem Klinikai Kozpont (4002)
  • Debreceni Egyetem Klinikai Kozpont (4025)
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Petz Aladar Megyei Oktato Korhaz
  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
  • Studium Egeszseghaz Kft
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Bacs-Kiskun Megyei Korhaz
  • Selye Janos Korhaz
  • Kanizsai Dorottya Korhaz
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Pecsi Tudomanyegyetem
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Csongrad Megyei Dr Bugyi Istvan Korhaz
  • Jeruzsalemhegyi Egeszseghaz
  • Zala Megyei Szent Rafael Korhaz
  • Daugavpils Regional Hospital
  • Dr Iveta Neniske GP Practice
  • Jelgava Outpatient Clinic
  • Dr R Eglite's Private practice
  • Inese Cebere GP practice
  • Pauls Stradins Clinical University Hospital
  • Clinic of GP A Lasmanis ALMA
  • GK Neiroklinika
  • Health Centre 4
  • Dr D Harasimjuka GP Practice
  • Regional Hospital of Ziemelkurzeme
  • Kaunas Clinical Hospital Public Institution
  • Saules Seimos Medicinos Centras JSC
  • Elite Medicale JSC
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103)
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Cardiology and Rehabilitation Clinic JSC
  • Klaipeda Republican Hospital Public Institution
  • Vilnius University Hospital Santariskiu Clinic Public Institution
  • CERMED
  • KLIMED Marek Klimkiewicz
  • KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
  • Synexus Polska SCM Sp z o o Gdansku
  • Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman
  • Synexus Polska Sp z o o Oddzial w Gdyni
  • Synexus Polska Sp z o o Oddzial w Katowicach
  • Grazyna Pulka Specjalistyczny Osrodek ALL-MED
  • Centrum Opieki Zdrowotnej Orkan-Med
  • Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak
  • Polimedica Centrum Badań Profilaktyki I Leczenia
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  • KLIMED Marek Klimkiewicz
  • Medicome Sp z o o
  • SPZOZ w Pulawach Szpital Specjalistyczny
  • Janusz Spyra Specjalistyczna Praktyka Lekarska
  • Centrum Medyczne Sabamed - Rzeszów
  • Centrum Medyczne Medyk
  • NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog
  • Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez
  • Synexus Polska Sp z o o Oddział w Warszawie
  • Synexus Polska Sp z o o Oddział we Wroclawiu
  • KO-MED Centra Kliniczne Zamosc
  • TSHI Altay Territorial Cardiologocal dispensary
  • City Hospital 1
  • FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
  • Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways
  • FSHI "MSU of MoIA of RF of Kemerovo Region"
  • SBIH of Moscow City Clinical Hospital 17
  • FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF
  • SBIH of Novosibirsk Region Clinical Emergency Hospital 2
  • Ultramed
  • SBEI HPE Orenburg State Medical University of the MoH of the RF
  • SPb SBIH City Hospital 38 n a N A Semashko
  • SBI of Ryazan region Regional Clinical Cardiological Dispensary
  • FSBIH SPb Clinical Hospital of RAS
  • FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine
  • StP SHI Clinical hospital of St Luka
  • SBI of HE Northwestern SMU n a I I Mechnikov
  • SHI "Center of Occupational Pathology"
  • LLC "Institute of Medical Investigations"
  • Pavlov First Saint Petersburg State Medical University
  • LLC Medical Institute on Krestovsky
  • North-West Federal Medical Research Center n a V A Almazov
  • SPb SBIH City Hospital 15
  • FSBI Saint-Petersburg Multidisciplinary Centre
  • SPB SHI Pokrovskaya City Hospital
  • SBEI HPE Smolensk State Medical University of the MoH of the RF
  • FSBI Research Institute for Cardiology of Siberian Branch RAMS
  • SBIH of Yaroslavl region Regional Clinical Hospital
  • Clinical Center of Serbia
  • Military Medical Academy
  • Clinical Center Dr Dragisa Misovic Dedinje
  • Dedinje Cardiovascular Institute
  • Clinical Center Bezanijska kosa
  • Clinical Center Kragujevac
  • Clinical Center Kragujevac
  • Niska Banja
  • Clinical Center Nis
  • Institute of Cardiovascular Diseases of Vojvodina
  • Stredoslovensky ustav srdcovych a cievnych chorob a s
  • Alian s r o
  • Cardioconsult s r o
  • DIAMETABOL s r o
  • Veria s r o
  • Medicalgroup s r o
  • KARDIO 1 s r o
  • Kardiologicka ambulancia Dr Kolikova
  • Medispol s r o
  • Interna SK s r o
  • MEDIVASA s r o
  • Hospital Virgen del Mar
  • Hospital del Mar
  • Hospital Quiron Barcelona
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Clinico San Carlos
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Parc Sanitari Sant Joan de Deu
  • Complejo Hospitalario Universitario de Santiago
  • Hospital Universitario Virgen Macarena
  • Hospital Nuestra Señora del Prado
  • Cherkasy Regional Cardiological Center
  • CI Cherkasy RH of Cherkasy Regional Council
  • Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU
  • Ivano-Frankivsk Regional Clinical Cardiology Dispensary
  • GI L T Malaya Therapy National Institute of the NAMS of Ukraine
  • Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
  • SI Institute of General & Emergency Surgery of NAMS of Ukraine
  • SMPI Central Clinical Hospital of Ukrzaliznytsia
  • CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU
  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Kyiv City Clinical Hospital 1
  • Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC
  • SI Heart Institute of the MoH of Ukraine
  • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)
  • SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)
  • CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
  • Regional State Clinical Treatment-Diagnostic Cardiological Centre
  • CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery
  • Multifield Medical Center of Odesa NMU (University Clinic 1)
  • First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy
  • Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU
  • M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1
  • CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU
  • O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC
  • CI Central City Hospital 2 of Zhytomyr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban 75 mg

Edoxaban 60 mg

Arm Description

Edoxaban 60 mg + edoxaban 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.

Edoxaban 60 mg + placebo 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.

Outcomes

Primary Outcome Measures

Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)
In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination
Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)
Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose
Pharmacodynamics: Mean exposure using validated assays
Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma. Categories: Edoxaban and its metabolite (D21-2393)
Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay
Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393

Secondary Outcome Measures

Efficacy: Number of participants with composite event 1
Composite event 1 includes ischemic or hemorrhagic stroke/transient ischemic attack (TIA) and systemic embolic events (SEE)
Efficacy: Number of participants with composite event 2
Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding
Safety: Number of participants with major bleeding (including intracranial)
Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition
Safety: Number of participants with clinically relevant bleeding
Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding
Safety: Number of participants with any bleeding
Count of participants who experienced any bleeding event

Full Information

First Posted
November 14, 2016
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo, Inc.
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02964949
Brief Title
Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes
Official Title
Evaluation of Edoxaban in Anticoagulant Naïve Patients With Nonvalvular Atrial Fibrillation (NVAF) and High Creatinine Clearance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
Collaborators
Quintiles, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Nonvalvular Atrial Fibrillation, High Creatinine Clearance, Developmental Phase III, Anticoagulant Naïve

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban 75 mg
Arm Type
Experimental
Arm Description
Edoxaban 60 mg + edoxaban 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.
Arm Title
Edoxaban 60 mg
Arm Type
Active Comparator
Arm Description
Edoxaban 60 mg + placebo 15 mg orally, once daily, at the same time (preferably morning) for up to 12 months, with a 2-4 week follow-up period. If needed when the patient completes or discontinues the study, an open-label transition dose of 30 mg and 15 mg edoxaban tablets will be provided.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.
Primary Outcome Measure Information:
Title
Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)
Description
In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination
Time Frame
After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Title
Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)
Description
Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose
Time Frame
After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Title
Pharmacodynamics: Mean exposure using validated assays
Description
Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma. Categories: Edoxaban and its metabolite (D21-2393)
Time Frame
Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Title
Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay
Description
Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393
Time Frame
Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Secondary Outcome Measure Information:
Title
Efficacy: Number of participants with composite event 1
Description
Composite event 1 includes ischemic or hemorrhagic stroke/transient ischemic attack (TIA) and systemic embolic events (SEE)
Time Frame
within 3 years
Title
Efficacy: Number of participants with composite event 2
Description
Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding
Time Frame
within 3 years
Title
Safety: Number of participants with major bleeding (including intracranial)
Description
Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition
Time Frame
within 3 years
Title
Safety: Number of participants with clinically relevant bleeding
Description
Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding
Time Frame
within 3 years
Title
Safety: Number of participants with any bleeding
Description
Count of participants who experienced any bleeding event
Time Frame
within 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets protocol-specified criteria for qualification Is able to follow the protocol specified contraception methods Is willing and able to comply with any restrictions related to food, drink and medications Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: the safety or well-being of the participant or study staff the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) the analysis of results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
O L V Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2260
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
C H U Brugmann - Site Victor Horta
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
St-Franciskus Ziekenhuis
City
Heusden-Zolder
ZIP/Postal Code
3550
Country
Belgium
Facility Name
Universitairsitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
C H R de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
AZ Turnhout - Campus Sint-Elisabeth
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
MHAT 'Sveta Ekaterina' EOOD
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Facility Name
MHAT Dr Tota Venkova AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Medical Center Haskovo EOOD
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
MHAT-Haskovo AD
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Facility Name
MHAT - Pazardzhik AD
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
MHAT Sv Pantaleymon - Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
SHATC Pleven EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT 'Dr Georgi Stranski' EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Sv Georgi EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT-Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Second MHAT - Sofia AD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Fifth MHAT - Sofia EAD
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
NMTH Tsar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT - National Heart Hospital EAD
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
UMHAT Alexandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT 'Tsaritsa Yoanna - ISUL' EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Fourth MHAT - Sofia EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT 'Sveta Anna' AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
SHATC Cardiolife OOD
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
General Hospital Dubrovnik
City
Dubrovnik
ZIP/Postal Code
20000
Country
Croatia
Facility Name
General Hospital Dr Tomislav Bardek
City
Koprivnica
ZIP/Postal Code
48000
Country
Croatia
Facility Name
Special Hospital for medical rehabilitation
City
Krapinske Toplice
ZIP/Postal Code
49217
Country
Croatia
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
General Hospital Dr Josip Bencevic
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
General Hospital Varazdin
City
Varazdin
ZIP/Postal Code
42000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Clinical Hospital Center Sestre Milosrdnice
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital center Zagreb (2108)
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital center Zagreb (2110)
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Innera s r o
City
Benesov
ZIP/Postal Code
256 01
Country
Czechia
Facility Name
Poliklinika Humanitas
City
Bilovec
ZIP/Postal Code
743. 01
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Edumed s.r.o
City
Broumov
ZIP/Postal Code
550 01
Country
Czechia
Facility Name
Nemocnice Havlickuv Brod, p.o.
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czechia
Facility Name
Kardio-Pisova, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
Oblastni nemocnice Kolin, a.s.
City
Kolin
ZIP/Postal Code
280 00
Country
Czechia
Facility Name
Centrum pro choroby srdce a cev
City
Kromeriz
ZIP/Postal Code
767 01
Country
Czechia
Facility Name
Kromerizska nemocnice, a.s.
City
Kromeriz
ZIP/Postal Code
767 01
Country
Czechia
Facility Name
InterKardioML s r o
City
Marianske Lazne
ZIP/Postal Code
353 01
Country
Czechia
Facility Name
PV - kardiologie s.r.o.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Corintez s.r.o
City
Prague
ZIP/Postal Code
158 00
Country
Czechia
Facility Name
Ordince pro choroby srdce a cev
City
Praha 10
ZIP/Postal Code
101 00
Country
Czechia
Facility Name
AVICENA -KARDIOLOGIE, INTERNA s.r.o.
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Nemocnice na Frantisku
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Kardio-Pisova sro
City
Praha
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Poliklinika RAVAK
City
Pribram 8
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Oblastni nemocnice Pribram, a.s.
City
Příbram
ZIP/Postal Code
261 95
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Poliklinika Masarykuv Dum, s.r.o.
City
Trutnov
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
Clinical Trials Services s.r.o
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Krajska nemocnice T Bati a s
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Amager Hospital
City
Copenhagen S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Bispebjeg og Fredeiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Holbæk Sygehus
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Nykøbing F Sygehus
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Slagelse Sygehus
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
101389
Country
Estonia
Facility Name
Dr Arvo Rosenthal LLC
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Principal SMO Kft
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Belgyogyaszati es Kardiologiai Maganrendelo
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Grof Tisza Istvan Korhaz
City
Berettyoujfalu
ZIP/Postal Code
4101
Country
Hungary
Facility Name
Budapesti Szent Ferenc Korhaz
City
Budapest
ZIP/Postal Code
1021
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Szent Margit Korhaz
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont (4002)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont (4025)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markhot Ferenc Oktatokorhaz es Rendelointezet
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Studium Egeszseghaz Kft
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Selye Janos Korhaz
City
Komarom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Kanizsai Dorottya Korhaz
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Csongrad Megyei Dr Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Jeruzsalemhegyi Egeszseghaz
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Dr Iveta Neniske GP Practice
City
Jekabpils
ZIP/Postal Code
LV-5201
Country
Latvia
Facility Name
Jelgava Outpatient Clinic
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Dr R Eglite's Private practice
City
Kuldiga
ZIP/Postal Code
LV-3301
Country
Latvia
Facility Name
Inese Cebere GP practice
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Clinic of GP A Lasmanis ALMA
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
GK Neiroklinika
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Health Centre 4
City
Riga
ZIP/Postal Code
LV-1012
Country
Latvia
Facility Name
Dr D Harasimjuka GP Practice
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Regional Hospital of Ziemelkurzeme
City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
Kaunas Clinical Hospital Public Institution
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
Facility Name
Saules Seimos Medicinos Centras JSC
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Elite Medicale JSC
City
Kaunas
ZIP/Postal Code
50177
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics (5103)
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Cardiology and Rehabilitation Clinic JSC
City
Klaipeda
ZIP/Postal Code
91131
Country
Lithuania
Facility Name
Klaipeda Republican Hospital Public Institution
City
Klaipeda
ZIP/Postal Code
92231
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic Public Institution
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
CERMED
City
Bialystok
ZIP/Postal Code
15-270
Country
Poland
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-765
Country
Poland
Facility Name
KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Synexus Polska SCM Sp z o o Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek med Krzysztof Cymerman
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Facility Name
Synexus Polska Sp z o o Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-384
Country
Poland
Facility Name
Synexus Polska Sp z o o Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Grazyna Pulka Specjalistyczny Osrodek ALL-MED
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Gabinet Internistyczno-Kardiologiczny Dr n. med. Jacek Nowak
City
Libiaz
ZIP/Postal Code
32-590
Country
Poland
Facility Name
Polimedica Centrum Badań Profilaktyki I Leczenia
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
City
Lodz
ZIP/Postal Code
93-153
Country
Poland
Facility Name
KLIMED Marek Klimkiewicz
City
Lomza
ZIP/Postal Code
18-404
Country
Poland
Facility Name
Medicome Sp z o o
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
SPZOZ w Pulawach Szpital Specjalistyczny
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Janusz Spyra Specjalistyczna Praktyka Lekarska
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Centrum Medyczne Sabamed - Rzeszów
City
Rzeszow
ZIP/Postal Code
35-006
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
NZOZ Pro-Cordis Sopockie Centrum Bad Kardiolog
City
Sopot
ZIP/Postal Code
81-717
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska B Busz-Papiez
City
Szczecin
ZIP/Postal Code
70-506
Country
Poland
Facility Name
Synexus Polska Sp z o o Oddział w Warszawie
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Synexus Polska Sp z o o Oddział we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
KO-MED Centra Kliniczne Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
TSHI Altay Territorial Cardiologocal dispensary
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
City Hospital 1
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Dep Clin Hosp on Station Kemerovo of OAO "Russian Railways
City
Kemerovo
ZIP/Postal Code
650055
Country
Russian Federation
Facility Name
FSHI "MSU of MoIA of RF of Kemerovo Region"
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
SBIH of Moscow City Clinical Hospital 17
City
Moscow
ZIP/Postal Code
119620
Country
Russian Federation
Facility Name
FSBI Russian Cardiological Scientific and Industrial Complex of the MoH of the RF
City
Moscow
ZIP/Postal Code
121522
Country
Russian Federation
Facility Name
SBIH of Novosibirsk Region Clinical Emergency Hospital 2
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Ultramed
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
SBEI HPE Orenburg State Medical University of the MoH of the RF
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
SPb SBIH City Hospital 38 n a N A Semashko
City
Pushkin
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
SBI of Ryazan region Regional Clinical Cardiological Dispensary
City
Ryazan'
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
FSBIH SPb Clinical Hospital of RAS
City
Saint Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
FFSBI The Nikiforov Russian Center of Emergency and Radiation Medicine
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
StP SHI Clinical hospital of St Luka
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
SBI of HE Northwestern SMU n a I I Mechnikov
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
SHI "Center of Occupational Pathology"
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
LLC "Institute of Medical Investigations"
City
Saint Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
LLC Medical Institute on Krestovsky
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
North-West Federal Medical Research Center n a V A Almazov
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
SPb SBIH City Hospital 15
City
Saint Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
FSBI Saint-Petersburg Multidisciplinary Centre
City
Saint Petersburg
ZIP/Postal Code
199004
Country
Russian Federation
Facility Name
SPB SHI Pokrovskaya City Hospital
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
SBEI HPE Smolensk State Medical University of the MoH of the RF
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
FSBI Research Institute for Cardiology of Siberian Branch RAMS
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
SBIH of Yaroslavl region Regional Clinical Hospital
City
Yaroslavl'
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Dr Dragisa Misovic Dedinje
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Dedinje Cardiovascular Institute
City
Belgrade
ZIP/Postal Code
11040
Country
Serbia
Facility Name
Clinical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institute of Cardiovascular Diseases of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Stredoslovensky ustav srdcovych a cievnych chorob a s
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Alian s r o
City
Bardejov
ZIP/Postal Code
8501
Country
Slovakia
Facility Name
Cardioconsult s r o
City
Bratislava
ZIP/Postal Code
81104
Country
Slovakia
Facility Name
DIAMETABOL s r o
City
Bratislava
ZIP/Postal Code
82106
Country
Slovakia
Facility Name
Veria s r o
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Medicalgroup s r o
City
Kosice
ZIP/Postal Code
4001
Country
Slovakia
Facility Name
KARDIO 1 s r o
City
Lucenec
ZIP/Postal Code
984 39
Country
Slovakia
Facility Name
Kardiologicka ambulancia Dr Kolikova
City
Povazska Bystrica
ZIP/Postal Code
1701
Country
Slovakia
Facility Name
Medispol s r o
City
Presov
ZIP/Postal Code
8001
Country
Slovakia
Facility Name
Interna SK s r o
City
Svidnik
ZIP/Postal Code
8901
Country
Slovakia
Facility Name
MEDIVASA s r o
City
Zilina
ZIP/Postal Code
1001
Country
Slovakia
Facility Name
Hospital Virgen del Mar
City
Almeria
ZIP/Postal Code
4120
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Quiron Barcelona
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Parc Sanitari Sant Joan de Deu
City
Sant Boi de Llobregat
ZIP/Postal Code
8830
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Nuestra Señora del Prado
City
Talavera de la Reina
ZIP/Postal Code
45600
Country
Spain
Facility Name
Cherkasy Regional Cardiological Center
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
CI Cherkasy RH of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Ivano-Frankivsk RCCD of MHU Dept of Arterial Hypertension SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Cardiology Dispensary
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
GI L T Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
SI Institute of General & Emergency Surgery of NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
SMPI Central Clinical Hospital of Ukrzaliznytsia
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
CI of Healthcare Kharkiv CCH 8 Dept of Cardiology for Patients with MI 2 Kharkiv MA of PGE of MOHU
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 1
City
Kyiv
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Med Center 'Ok!Clinic' of International Institute of Clinical Trials LLC
City
Kyiv
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
SI Heart Institute of the MoH of Ukraine
City
Kyiv
ZIP/Postal Code
2660
Country
Ukraine
Facility Name
SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9102)
City
Kyiv
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
SI NSС M D Strazhesko Institute of Cardiology of NAMSU (9116)
City
Kyiv
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
City
Luts'k
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Regional State Clinical Treatment-Diagnostic Cardiological Centre
City
Lviv
ZIP/Postal Code
79015
Country
Ukraine
Facility Name
CI Odesa Regional Clinical Hospital Regional Center of Cardiosurgery
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Multifield Medical Center of Odesa NMU (University Clinic 1)
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
First CCH Cardiology Dept SHEIU Ukrainian Medical Stomatological Academy
City
Poltava
ZIP/Postal Code
36038
Country
Ukraine
Facility Name
Transcarpathian RC Cardiology Dispensary Dept of General Cardiology SHEI Uzhgorod NU
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
M I Pyrogov VRCH M I Pyrogov VNMU Ch of IM 1
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
CI Zaporizhzhia Cl Hosp 10 Dept of Therapy SI ZMA of PGE of MoHU
City
Zaporizhzhya
ZIP/Postal Code
69001
Country
Ukraine
Facility Name
O F Herbachevskyi Regional Clinical Hospital of Zhytomyr RC
City
Zhytomyr
ZIP/Postal Code
10003
Country
Ukraine
Facility Name
CI Central City Hospital 2 of Zhytomyr
City
Zhytomyr
ZIP/Postal Code
10004
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

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