drugset / Trial / 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

NCT06718179

Phase 4 Recruiting 3150 enrolled Odense University Hospital
RandomizedParallel-groupSingle-blindTreatment

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)

Timeline

Start
2024-11-16
Primary completion
2029-11
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 75 mg
Background Prasugrel Small molecule 5 mg
Background Prasugrel Small molecule 10 mg