Actively Recruiting
Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Led by Odense University Hospital · Updated on 2025-03-03
3150
Participants Needed
3
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with acute coronary syndromes treated with an everolimus-eluting drug-eluting stent
- Able to be treated with prasugrel for 12 months
- Postmenopausal women or women using contraceptive drugs (no menstruation for at least 12 consecutive months or continuous use of contraceptive implants, intrauterine devices, birth-control pills, patches, vaginal rings, or injections)
You will not qualify if you...
- Under 18 years of age
- Unable to consent to participate (e.g., intubated patients)
- Do not speak Danish
- Life expectancy less than 1 year
- Allergy to study treatments
- Currently treated with non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin
- Contraindication to prasugrel treatment for 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
L
Lisette O Jensen, MD
CONTACT
E
Evald H Christiansen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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