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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

NCT06718179 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3150

Last updated 2025-03-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lisette O Jensen, MD · Odense University Hospital

  • Evald H Christiansen, MD · Aarhus University Hospital

  • Ashkan Eftekhari, MD · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-16
Primary Completion
2029-11-30
Completion
2030-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06718179 on ClinicalTrials.gov