Clinical trial NCT06718179: Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Drug-eluting stent
Dual antiplatelet treatment
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 3150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Number of patients with clinically relevant bleeding (Effectiveness)
timeFrame: 1 year
measure: Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety)
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with clinically relevant bleeding
timeFrame: 1 year
measure: Number of patients with all-cause death
timeFrame: 1 year
measure: Number of patients with cardiac death
timeFrame: 1 year
measure: Number of patients with myocardial infarction
timeFrame: 1 year
measure: Number of patients with definite stent thrombosis
timeFrame: 1 year
measure: Number of patients with target lesion revascularization
timeFrame: 1 year
measure: Number of patients with stroke
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 month and 1 year
measure: Angina status
timeFrame: 1 month and 1 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lisette O Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Ashkan Eftekhari, MD
role: PRINCIPAL_INVESTIGATOR
References: