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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

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

Recruiting
18 years and older
All
Phase 4

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Overview

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

Inclusion Criteria:

  • All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
  • Postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection).

Exclusion Criteria:

  • Age < 18 years
  • Not able to consent to study participating (eg. intubated patients)
  • Do not speak Danish
  • Life expectancy <1 year
  • Allergic to study related treatment
  • Non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin treatment
  • Contraindication for 12 months prasugrel treatment

Study details
    Acute Coronary Syndrome

NCT06718179

Odense University Hospital

30 March 2025

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