Study to gather information about the proper dosing and safety of the oral FXIa inhibitor BAY 2433334 in patients following an acute heart attack
- Conditions
- Acute Myocardial InfarctionMedDRA version: 21.1Level: PTClassification code 10064939Term: Cardiovascular event prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-003244-79-AT
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1600
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>• 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<br>Time from randomization to first occurrence of any of the components of the composite outcome including CV death, MI, stroke and stent thrombosis<br>Safety Endpoint:<br>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 Outcome Measures
Name Time Method Secondary end point(s): Efficacy Endpoints:<br>1. Time from randomization to death (all cause mortality)<br>2. Time from randomization to CV death<br>3. Time from randomization to first occurrence of MI<br>4. Time from randomization to first occurrence of stroke (ischemic and hemorrhagic)<br>5. Time from randomization to first occurrence of stent thrombosis<br>Safety Endpoints:<br>1. Time from randomization to first occurrence of all bleeding<br>2. Time from randomization to first occurrence of BARC bleeding definition Type 3, 5<br>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