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Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (PACIFIC-AMI)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY2433334
BAY2433334 matching placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

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

Inclusion Criteria:

  • Participants must be 45 years of age or older, at the time of signing the informed consent

  • Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:

    • clinical symptoms of acute myocardial infarction AND
    • elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND

    • at least one of the following risk factors need to be fulfilled:

      • Age ≥ 65 years
      • Prior MI (before the index AMI event)
      • Prior peripheral arterial disease
      • Diabetes Mellitus
      • Prior coronary artery bypass grafting (CABG) AND
    • initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization)
  • Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI
  • Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.

Exclusion Criteria:

  • Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization
  • Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization
  • Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.

Sites / Locations

  • Valley Clinical Trials, Inc. - Covina
  • Florida Premier Cardiology
  • Clearwater Cardiovascular Associates | Clearwater, FL
  • Cardiology Associates Research Company
  • Southwest Florida Research
  • Cardiology Partners Clinical Research Institute
  • Columbus Regional Research Institute
  • Reid Health
  • Midwest Heart & Vascular Specialists
  • Cardiovascular Associates Research, LLC
  • Southern Clinical Research, LLC
  • Maryland Cardiovascular Specialists
  • White Oak Medical Center
  • St. Mary's/Duluth Clinic Health System
  • Logan Health Research
  • Methodist Physicians Clinic
  • The Valley Hospital, Inc.
  • Trinity Medical WNY
  • Jefferson Heart Institute
  • Cardiovascular Research of Knoxville
  • PharmaTex Research, LLC
  • North Texas Research Associates
  • Klinikum Klagenfurt am Wörthersee
  • Universitätsklinikum St. Pölten
  • Landesklinikum Wiener Neustadt
  • Krankenhaus St. Josef Braunau
  • Kepler Universitätsklinikum Campus III
  • Medizinische Universität Graz
  • Universitätsklinikum AKH Wien
  • Klinik Ottakring - Wilhelminenspital
  • Klinik Floridsdorf - Krankenhaus Nord
  • OL Vrouwziekenhuis - Campus Aalst
  • Imeldaziekenhuis - St-Elisabethkliniek
  • AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
  • CU Saint-Luc/UZ St-Luc
  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis
  • UZ Leuven Gasthuisberg
  • CHR de la Citadelle - Cardiology
  • Fakultni nemocnice Brno
  • Fakultni nemocnice u sv. Anny
  • Nemocnice Ceske Budejovice, a.s. Department of kardiologie
  • Fakultni Nemocnice Hradec Kralove
  • Fakultni nemocnice Plzen - Lochotin
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • Institut Klinicke a Experimentalni Mediciny
  • Fakultni nemocnice v Motole
  • Ustredni vojenska nemocnice Praha
  • Nemocnice Slany
  • Universitätsherzzentrum Freiburg - Bad Krozingen
  • Universitätsklinikum Essen
  • St. Vinzenz-Hospital
  • Kliniken Maria Hilf GmbH
  • Sana-Klinikum Remscheid GmbH
  • Forschungszentrum Ruhr - KliFoCenter GmbH
  • Universitätsmedizin der Johannes Gutenberg Universität Mainz
  • Krankenhaus Dresden-Friedrichstadt
  • Universitätsklinikum Hamburg Eppendorf (UKE)
  • Universitätsklinikum Heidelberg
  • Allami Szivkorhaz
  • Budai Irgalmasrendi Korhaz
  • University of Semmelweis/ Semmelweis Egyetem
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Petz Aladar Megyei Oktato Korhaz
  • Pandy Kalman Korhaz
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Josa Andras Hospital
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
  • Zala Megyei Szent Rafael Korhaz
  • A.O. San Pio
  • ASL Caserta
  • A.O.U. di Ferrara
  • Asl Roma 2
  • IRCCS Ospedale Policlinico San Martino
  • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
  • IRCCS Centro Cardiologico Monzino S.p.A
  • ASST Valle Olona
  • A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
  • A.O. S.Croce e Carle
  • ASL TO3 di Collegno e Pinerolo
  • A.O.U. di Sassari
  • AUSL Toscana Sud-Est
  • ULSS3 Serenissima
  • Daido Hospital, Social Medical Corporation Kojunkai
  • Chiba-Nishi General Hospital
  • Fukuoka Tokushukai Hospital
  • Kokura Memorial Hospital
  • Ogaki Municipal Hospital
  • Hokkaido Cardiovascular Hospital
  • Hyogo Prefectural Harima-Himeji General Medical Center
  • Takahashi Hospital
  • Nishinomiya Watanabe Cardiovascular Center
  • Tsukuba Medical Center Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Kishiwada Tokushukai Hospital
  • Shin-Kuki General Hospital
  • Saitama Sekishinkai Hospital
  • Tokyo Medical and Dental University Hospital
  • Fukui Prefectural Hospital
  • Japanese Red Cross Fukuoka Hospital
  • Saiseikai Kumamoto Hospital
  • Oita Prefectural Hospital
  • Osaka General Medical Center
  • Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar
  • Reinier de Graaf Gasthuis
  • Jeroen Bosch Ziekenhuis
  • Albert Schweitzer Ziekenhuis, Dordwijk
  • Zuyderland Medisch Centrum
  • Elkerliek Ziekenhuis, Lokatie Helmond
  • Leids Universitair Medisch Centrum
  • Universitair Medisch Centrum St. Radboud
  • Canisius Wilhelmina Ziekenhuis
  • Bravis Ziekenhuis
  • Ikazia Ziekenhuis
  • VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo
  • Gelre Ziekenhuizen Zutphen
  • Isala
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Szpital sw. Wincentego a Paulo
  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni
  • Uniwersytecki Szpital Kliniczny w Opolu
  • Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
  • Uniwersyteckie Centrum Kliniczne Warszawskiego UM
  • Szpital Grochowski im. dr.med. Rafala Masztaka
  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu
  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Hospital de la Santa Creu i de Sant Pau | Cardiología
  • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
  • Hospital Universitario Virgen de las Nieves|Cardiologia
  • Hospital Ramon y Cajal | Cardiologia
  • Hospital Clinico Universitario San Carlos | Cardiologia
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke
  • Hospital Universitario Virgen de la Macarena
  • Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia
  • Hospital Gral. Univ. de Valencia | Cardiologia
  • Hospital Universitari i Politècnic La Fe | Cardiología
  • Falu Lasarett
  • Sahlgrenska Universitetssjukhuset
  • Länssjukhuset Ryhov
  • Skånes Universitetssjukhus
  • Danderyds sjukhus
  • Länssjukhuset Sundsvall-Härnösand
  • Akademiska sjukhuset Hjärtforskningsmottagningen
  • Västmanlands Sjukhus Västerås
  • Universitetssjukhuset Örebro
  • Kantonsspital Aarau
  • Kantonsspital Baselland - Standort Liestal
  • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Kantonsspital Baden
  • Hôpital Cantonal Universitaire de Genève
  • Ospedale regionale di Lugano
  • Luzerner Kantonsspital
  • Lister Hospital
  • Freeman Hospital
  • Worcestershire Acute Hospital Trust
  • Imperial College London
  • Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BAY 2433334 high dose

BAY 2433334 medium dose

BAY 2433334 low dose

BAY2433334 matching placebo

Arm Description

Outcomes

Primary Outcome Measures

Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)
CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5
Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.

Secondary Outcome Measures

Efficacy - Number of Participants With CV Death
CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.
Efficacy - Number of Participants With MI
Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.
Efficacy - Number of Participants With Stroke
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.
Efficacy - Number of Participants With Stent Thrombosis
ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Efficacy - Number of Participants With All Cause Mortality
Safety - Number of Participants With All Bleeding
All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention
Safety - Number of Participants With BARC Bleeding Definition Type 3, 5
Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.
Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5
Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.

Full Information

First Posted
March 8, 2020
Last Updated
April 3, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04304534
Brief Title
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
Acronym
PACIFIC-AMI
Official Title
Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
February 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY 2433334 high dose
Arm Type
Experimental
Arm Title
BAY 2433334 medium dose
Arm Type
Experimental
Arm Title
BAY 2433334 low dose
Arm Type
Experimental
Arm Title
BAY2433334 matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BAY2433334
Intervention Description
Tablet, taken orally once a day.
Intervention Type
Other
Intervention Name(s)
BAY2433334 matching placebo
Intervention Description
Tablet, taken orally once a day.
Primary Outcome Measure Information:
Title
Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)
Description
CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame
From baseline up to 52 weeks
Title
Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5
Description
Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.
Time Frame
From baseline up to 52 weeks
Secondary Outcome Measure Information:
Title
Efficacy - Number of Participants With CV Death
Description
CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.
Time Frame
From baseline up to 52 weeks
Title
Efficacy - Number of Participants With MI
Description
Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.
Time Frame
From baseline up to 52 weeks
Title
Efficacy - Number of Participants With Stroke
Description
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.
Time Frame
From baseline up to 52 weeks
Title
Efficacy - Number of Participants With Stent Thrombosis
Description
ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause
Time Frame
From baseline up to 52 weeks
Title
Efficacy - Number of Participants With All Cause Mortality
Time Frame
From baseline up to 52 weeks
Title
Safety - Number of Participants With All Bleeding
Description
All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention
Time Frame
From baseline up to 52 weeks
Title
Safety - Number of Participants With BARC Bleeding Definition Type 3, 5
Description
Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.
Time Frame
From baseline up to 52 weeks
Title
Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5
Description
Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.
Time Frame
From baseline up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be 45 years of age or older, at the time of signing the informed consent Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with: clinical symptoms of acute myocardial infarction AND elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND at least one of the following risk factors need to be fulfilled: Age ≥ 65 years Prior MI (before the index AMI event) Prior peripheral arterial disease Diabetes Mellitus Prior coronary artery bypass grafting (CABG) AND initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization) Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure. Exclusion Criteria: Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.
Facility Information:
Facility Name
Valley Clinical Trials, Inc. - Covina
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Florida Premier Cardiology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Clearwater Cardiovascular Associates | Clearwater, FL
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Cardiology Associates Research Company
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Southwest Florida Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Cardiology Partners Clinical Research Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Midwest Heart & Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Cardiovascular Associates Research, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Southern Clinical Research, LLC
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Maryland Cardiovascular Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
White Oak Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
St. Mary's/Duluth Clinic Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Logan Health Research
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Methodist Physicians Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
The Valley Hospital, Inc.
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Trinity Medical WNY
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14227
Country
United States
Facility Name
Jefferson Heart Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Cardiovascular Research of Knoxville
City
Powell
State/Province
Tennessee
ZIP/Postal Code
37849
Country
United States
Facility Name
PharmaTex Research, LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79109
Country
United States
Facility Name
North Texas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
State/Province
Kärnten
ZIP/Postal Code
9020
Country
Austria
Facility Name
Universitätsklinikum St. Pölten
City
St. Pölten
State/Province
Niederösterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Landesklinikum Wiener Neustadt
City
Wiener Neustadt
State/Province
Niederösterreich
ZIP/Postal Code
2700
Country
Austria
Facility Name
Krankenhaus St. Josef Braunau
City
Braunau
State/Province
Oberösterreich
ZIP/Postal Code
5280
Country
Austria
Facility Name
Kepler Universitätsklinikum Campus III
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Ottakring - Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Klinik Floridsdorf - Krankenhaus Nord
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
OL Vrouwziekenhuis - Campus Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Imeldaziekenhuis - St-Elisabethkliniek
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Sint-Jan Brugge-Oostende | Sint-Jan - Cardiology
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHR de la Citadelle - Cardiology
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Ceske Budejovice, a.s. Department of kardiologie
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Plzen - Lochotin
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Institut Klinicke a Experimentalni Mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Ustredni vojenska nemocnice Praha
City
Praha 6
ZIP/Postal Code
169 02
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Universitätsherzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
St. Vinzenz-Hospital
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50733
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
Facility Name
Sana-Klinikum Remscheid GmbH
City
Remscheid
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42859
Country
Germany
Facility Name
Forschungszentrum Ruhr - KliFoCenter GmbH
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Krankenhaus Dresden-Friedrichstadt
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf (UKE)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Allami Szivkorhaz
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
University of Semmelweis/ Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Josa Andras Hospital
City
Nyiregyhaza
ZIP/Postal Code
H-4400
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Zala Megyei Szent Rafael Korhaz
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
A.O. San Pio
City
Benevento
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
Facility Name
ASL Caserta
City
Caserta
State/Province
Campania
ZIP/Postal Code
81031
Country
Italy
Facility Name
A.O.U. di Ferrara
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Facility Name
Asl Roma 2
City
Roma
State/Province
Lazio
ZIP/Postal Code
00157
Country
Italy
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
IRCCS Centro Cardiologico Monzino S.p.A
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20138
Country
Italy
Facility Name
ASST Valle Olona
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21047
Country
Italy
Facility Name
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Facility Name
A.O. S.Croce e Carle
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
ASL TO3 di Collegno e Pinerolo
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10098
Country
Italy
Facility Name
A.O.U. di Sassari
City
Sassari
State/Province
Sardegna
Country
Italy
Facility Name
AUSL Toscana Sud-Est
City
Grosseto
State/Province
Toscana
ZIP/Postal Code
58100
Country
Italy
Facility Name
ULSS3 Serenissima
City
Venezia
State/Province
Veneto
ZIP/Postal Code
30035
Country
Italy
Facility Name
Daido Hospital, Social Medical Corporation Kojunkai
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Chiba-Nishi General Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2251
Country
Japan
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Hokkaido Cardiovascular Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-8622
Country
Japan
Facility Name
Hyogo Prefectural Harima-Himeji General Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8560
Country
Japan
Facility Name
Takahashi Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654-0026
Country
Japan
Facility Name
Nishinomiya Watanabe Cardiovascular Center
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
662-0911
Country
Japan
Facility Name
Tsukuba Medical Center Hospital
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8558
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Shin-Kuki General Hospital
City
Kuki
State/Province
Saitama
ZIP/Postal Code
346-8530
Country
Japan
Facility Name
Saitama Sekishinkai Hospital
City
Sayama
State/Province
Saitama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Japanese Red Cross Fukuoka Hospital
City
Fukuoka
ZIP/Postal Code
815-8555
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Oita Prefectural Hospital
City
Oita
ZIP/Postal Code
870-8511
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Reinier de Graaf Gasthuis
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Elkerliek Ziekenhuis, Lokatie Helmond
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Bravis Ziekenhuis
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Gelre Ziekenhuizen Zutphen
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AZ
Country
Netherlands
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Szpital sw. Wincentego a Paulo
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Opolu
City
Opole
ZIP/Postal Code
45-401
Country
Poland
Facility Name
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Szpital Grochowski im. dr.med. Rafala Masztaka
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i de Sant Pau | Cardiología
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves|Cardiologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Ramon y Cajal | Cardiologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos | Cardiologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca | Neurology Department - Stroke
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Inst Investigacio Sanitaria Pere Virgili | Hosp Univ Joan XXIII de Tarragona - Neurology - Stroke, No-Cardioembolic-Tia
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Hospital Gral. Univ. de Valencia | Cardiologia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe | Cardiología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Länssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Skånes Universitetssjukhus
City
Lund
ZIP/Postal Code
222 42
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Länssjukhuset Sundsvall-Härnösand
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Akademiska sjukhuset Hjärtforskningsmottagningen
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Västmanlands Sjukhus Västerås
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Universitetssjukhuset Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Kantonsspital Baselland - Standort Liestal
City
Liestal
State/Province
Basel-Landschaft
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Hôpital Cantonal Universitaire de Genève
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Ospedale regionale di Lugano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Lister Hospital
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Worcestershire Acute Hospital Trust
City
Worcester
State/Province
Worcestershire
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Citations:
PubMed Identifier
36030390
Citation
Rao SV, Kirsch B, Bhatt DL, Budaj A, Coppolecchia R, Eikelboom J, James SK, Jones WS, Merkely B, Keller L, Hermanides RS, Campo G, Ferreiro JL, Shibasaki T, Mundl H, Alexander JH; PACIFIC AMI Investigators. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction. Circulation. 2022 Oct 18;146(16):1196-1206. doi: 10.1161/CIRCULATIONAHA.122.061612. Epub 2022 Aug 27. Erratum In: Circulation. 2022 Dec 6;146(23):e330.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
URL
http://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

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