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Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Sponsor: Odense University Hospital
Summary
The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
Official title: Randomized Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents (SORT OUT XII DAPT Duration Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3150
Start Date
2024-11-16
Completion Date
2030-12
Last Updated
2025-03-03
Healthy Volunteers
No
Conditions
Interventions
Short duration of aspirin and prasugrel
aspirin 75 mg/day for 1 months plus prasugrel 10 mg/day (5 mg/day) for 1 year, followed by lifelong aspirin 75 mg/day after 1 year
Conventional duration of aspirin and prasugrel
aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year
Locations (3)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark