Comparing short versus long-term dual antiplatelet therapy in heart patients
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)
This study is testing whether a shorter course of dual antiplatelet therapy with prasugrel and aspirin is safer and just as effective for heart patients who have had a procedure to open blocked arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 3 sites (Aalborg and 2 other locations) |
| Trial ID | NCT06718179 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of short-term versus 12-month dual antiplatelet therapy using prasugrel and aspirin in patients with acute coronary syndromes who have undergone percutaneous coronary intervention with everolimus-eluting stents. It is a randomized controlled trial designed to assess whether the shorter duration of treatment is superior in terms of bleeding risks while maintaining safety regarding serious cardiac events. The study will enroll patients aged 18 and older who meet specific criteria for treatment with prasugrel. The outcomes will focus on clinically relevant bleeding and major cardiovascular events.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acute coronary syndromes treated with everolimus-eluting stents.
Not a fit: Patients under 18, those unable to consent, or those with contraindications to prasugrel will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine a safer and more effective duration for dual antiplatelet therapy, potentially reducing bleeding risks for patients.
How similar studies have performed: Other studies have explored dual antiplatelet therapy durations, but this specific comparison of short versus long-term treatment in this patient population is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 2 other locations
- Aalborg University Hospital — Aalborg, Denmark (Not_yet_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Lisette O Jensen, MD — Odense University Hospital
- Study coordinator: Lisette O Jensen, MD
- Email: lisette.okkels.jensen@rsyd.dk
- Phone: +4565412690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.