Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Short duration of aspirin and prasugrelConventional duration of aspirin and prasugrel
Short duration of aspirin and prasugrel: aspirin 75 mg/day for 1 months plus prasugrel 10 mg/day (5 mg/day) for 1 year, followed by lifelong aspirin 75 mg/day after 1 year
Conventional duration of aspirin and prasugrel: aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of patients with clinically relevant bleeding (Effectiveness) — 1 year Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) where BARC group 2, 3 and 5 are registered
Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety) — 1 year Major adverse cardiovascular or cerebrovascular events (MACCE) is defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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