Acute myocardial infarction
Conditions
Sponsors
Bayer Yakuhin, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Participants must be 45 years of age or older, at the time of signing theinformed 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Time from randomization to first occurrence of any of the components of the composite outcome including Cardiovascular (CV) death, Myocardial infarction (MI), stroke and stent thrombosis [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding definition type 2, 3 and 5 [Time Frame: From baseline up to 12 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Time from randomization to death (all cause mortality) [Time Frame: From baseline up to 12 months] Time from randomization to CV death [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of MI [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of stroke (ischemic and hemorrhagic) [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of stent thrombosis [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of all bleeding [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of BARC bleeding definition Type 3, 5 [Time Frame: From baseline up to 12 months] Time from randomization to first occurrence of BARC bleeding definition Type 1, 2, 3, 5 [Time Frame: From baseline up to 12 months] | — |
Countries
Europe, Japan, North America
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed