NCT06718179

Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,150 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	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
DRUG	Conventional duration of aspirin and prasugrel	aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year

Timeline

• Start date: 2024-11-16
• Primary completion: 2029-11-01
• Completion: 2030-12-01
• First posted: 2024-12-05
• Last updated: 2025-03-03

Locations

3 sites across 1 country: Denmark