NCT06718179TerminatedPhase 4
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)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Reason given: Insufficient drug supply (prasugrel)
Brief summary (registry, in English)
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)
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 12 Nov 2024
- Start date
- 16 Nov 2024
- Primary completion date
- 25 May 2025
- Lead sponsor
- Odense University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06718179
- EU CT number
- 2024-515236-69-00
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic to study related treatment
Age
- Age < 18 years
Other
- Not able to consent to study participating (eg. intubated patients)
- Do not speak Danish
- Life expectancy <1 year
- Non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin treatment
- Contraindication for 12 months prasugrel treatment
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Unknown status |
| Aarhus University Hospital | Aarhus | Denmark | Unknown status |
| Odense University Hospital | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.