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
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Acute Myocardial Infarction
- Registration Number
- EUCTR2019-003244-79-IT
- Lead Sponsor
- BAYER AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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
- Secondary Outcome Measures
Name Time Method