Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: BAY2433334; BAY2433334 matching placebo
Intervention description: Tablet, taken orally once a day.; Tablet, taken orally once a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1601.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      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 criteria:

        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:

                    -  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

          -  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:

          -  Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of
             randomization

          -  Active bleeding; known bleeding disorder, history of major bleeding (intracranial,
             retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding
             within last 6 months of randomization

          -  Planned use or requirement of full dose and long term anticoagulation therapy during
             study conduct.