Pacific AMI

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

Objective

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.

Eligibility

  • 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

 

NCT ID

NCT04304534