Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04304534
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04304534
Study Brief:
Protocol Section:
NCT04304534