Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
