heart attack myocardial infarction
Conditions
Interventions
Random (1:1) allocation to dual therapy (OAC + 1 year P2Y12 inhibitor) versus
triple therapy (OAC + 1 year P2Y12 inhibitor + 1-12 moths ASA).
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Over 18 years of age Acute coronary syndrome with elevated cardiac enzymes Atrial fibrillation with long-term indication for oral anticoagulation
Exclusion criteria
Exclusion criteria: Severe bleeding in past 3 months Known coagulopathy Contra-indications for intended medication (NOAC, P2Y12-remmer, ASA) eGFR < 15 min/kg/1.73m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: composed endpoint of all-cause death, MI, stroke, systemic embolism, stent thrombosis. Primary safety endpoint: ISTH major + clinically relevant non-major bleeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: separate components of primary endpoints, net clinical benefit, quality of life. | — |
Countries
Netherlands
Outcome results
None listed