Acute Myocardial Infarction MedDRA version: 21.1 Level: PT Classification code 10064939 Term: Cardiovascular event prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be 45 years of age or older, at the time of signing the informed consent 2. Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with: a.clinical symptoms of acute myocardial infarction AND b.elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme [CK-MB] or cardiac troponins) AND c.at least one of the following risk factors need to be fulfilled: i. Age = 65 years ii.Prior MI (before the index AMI event) iii.Prior peripheral arterial disease iv.Diabetes Mellitus v.Prior coronary artery bypass grafting (CABG) AND d. 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) 3. Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI 4. Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800
Exclusion criteria
Exclusion criteria: 1. Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization 2. Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization 3. Planned use or requirement of full dose and long term anticoagulation therapy during study conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate whether the oral FXIa inhibitor BAY 2433334 compared to placebo leads to a lower incidence of cardiovascular (CV) death, MI, stroke and stent thrombosis in participants with an acute myocardial infarction and who are treated with dual antiplatelet therapy. • To evaluate whether the incidence of bleeding is similar for BAY 2433334 compared to placebo in participants with an acute myocardial infarction and who are treated with dual antiplatelet therapy;Secondary Objective: Not applicable;Primary end point(s): Efficacy Endpoint Time from randomization to first occurrence of any of the components of the composite outcome including CV death, MI, stroke and stent thrombosis Safety Endpoint: Time from randomization to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding definition type 2, 3 and 5;Timepoint(s) of evaluation of this end point: From baseline up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: 1. Time from randomization to death (all cause mortality) 2. Time from randomization to CV death 3. Time from randomization to first occurrence of MI 4. Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) 5. Time from randomization to first occurrence of stent thrombosis Safety Endpoints: 1. Time from randomization to first occurrence of all bleeding 2. Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 3. Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5;Timepoint(s) of evaluation of this end point: From baseline up to 12 months | — |
Countries
Austria, Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain, Swaziland, Sweden, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed