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Recruiting 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

Phase IV Interventional Acute Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short duration of aspirin and prasugrel, Conventional duration of aspirin and prasugrel.
Who it may be relevant to
Registry conditions: Acute Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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)

Interventions

  • Drug 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
  • Drug Conventional duration of aspirin and prasugrel
    aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year

Primary outcome measures

  • Number of patients with clinically relevant bleeding (Effectiveness) [Time frame: 1 year]
  • Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety) [Time frame: 1 year]
Secondary outcome measures (9)
  • Number of patients with clinically relevant bleeding [Time frame: 1 year]
  • Number of patients with all-cause death [Time frame: 1 year]
  • Number of patients with cardiac death [Time frame: 1 year]
  • Number of patients with myocardial infarction [Time frame: 1 year]
  • Number of patients with definite stent thrombosis [Time frame: 1 year]
  • Number of patients with target lesion revascularization [Time frame: 1 year]
  • Number of patients with stroke [Time frame: 1 year]
  • Health-related quality of life [Time frame: 1 month and 1 year]
  • Angina status [Time frame: 1 month and 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 3 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Odense University Hospital — Odense

Identifiers

NCT: NCT06718179 · SORT OUT XII DAPT Duration · 2024-515236-69-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗