Patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) (biomarker -positive acute coronary syndrome) undergoing PCI
Conditions
Brief summary
Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization, Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization
Detailed description
All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization, Cardiovascular mortality at 6 weeks after randomization, Bleeding (BARC type ≥ 2) at 6 weeks after randomization, Urgent revascularization at 6 weeks after randomization, All-cause mortality at 6 months after randomization, Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization, Ischaemic stroke at 6 months after randomization
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) at 6 weeks after randomization, Primarys safety endpoint: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) at 6 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization, Cardiovascular mortality at 6 weeks after randomization, Bleeding (BARC type ≥ 2) at 6 weeks after randomization, Urgent revascularization at 6 weeks after randomization, All-cause mortality at 6 months after randomization, Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization, Ischaemic stroke at 6 months after randomization | — |
Countries
Austria, Germany