RecruitingPhase 4NCT06718179

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)


Sponsor

Odense University Hospital

Enrollment

3,150 participants

Start Date

Nov 16, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Conventional duration of aspirin and prasugrel and a drug called Short duration of aspirin and prasugrel for people with acute coronary syndrome. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGShort 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

DRUGConventional 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

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NCT06718179


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