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

Last updated: February 26, 2025
Sponsor: Odense University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Cardiac Disease

Chest Pain

Myocardial Ischemia

Treatment

Conventional duration of aspirin and prasugrel

Short duration of aspirin and prasugrel

Clinical Study ID

NCT06718179
SORT OUT XII DAPT Duration
2024-515236-69-00
  • Ages > 18
  • All Genders

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients aged ≥18 years with acute coronary syndromes who are treated with aneverolimus-eluting drug-eluting stent can undergo randomization if they can betreated with prasugrel for 12 months.

  • Postmenopausal women or use of contraceptive drugs (absence of menstruation in atleast 12 consecutive months or continuously usage of contraceptive drugs (acontraceptive implant, an intrauterine device, birth-control pills, transdermalpatches, vaginal ring, or depot injection).

Exclusion

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 Design

Total Participants: 3150
Treatment Group(s): 2
Primary Treatment: Conventional duration of aspirin and prasugrel
Phase: 4
Study Start date:
November 16, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

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