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 now · Phase 4
Conditions studied: Acute Coronary Syndrome
In brief
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)
Key facts
- Study ID
- NCT06718179
- Run by
- Odense University Hospital
- People needed
- 3150
- Starts
- 2024-11-16
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
- Aalborg University Hospital — Aalborg, Denmark
Full record on ClinicalTrials.gov
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