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
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
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.
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:
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:
Bruxelles - Brussel, 1200, Belgium
Mainz, Rhineland-Palatinate 55131, Germany
Bunkyo-ku, Tokyo 113-8519, Japan
Barcelona, 08907, Spain
Murcia, 30120, Spain
Tarragona, 43005, Spain