Actively Recruiting

Phase 4
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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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