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 DAPT)

Odense University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Conventional duration of aspirin and prasugrel; Drug: Short duration of aspirin and prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT06718179

SORT OUT XII DAPT Duration

2024-515236-69-00 (EU Trial (CTIS) Number)

Details and patient eligibility

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)

Enrollment: 3,150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,150 participants in 2 patient groups

Short duration of DAPT

Experimental group

Treatment:

Drug: Short duration of aspirin and prasugrel

Conventional duration of DAPT

Active Comparator group

Treatment:

Drug: Conventional duration of aspirin and prasugrel