Last updated on October 2020

Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Myocardial Infarction
  • Age: Between 45 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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