Comparing anti-platelet therapy durations in kidney disease patients after stent placement
Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
This study is testing whether taking anti-platelet medication for 6 months instead of 3 months helps people with advanced kidney disease feel better after getting heart stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 19 Years to 84 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04708587 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the clinical outcomes of different durations of dual anti-platelet therapy, specifically aspirin combined with either clopidogrel or prasugrel, in patients with advanced chronic kidney disease who have undergone percutaneous coronary intervention using new generation drug eluting stents. It is a prospective, open-label, multicenter randomized trial that will compare the effects of at least 6 months of therapy against 3 months or less. The study seeks to determine the optimal duration of anti-platelet therapy to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 years old with advanced chronic kidney disease (Stages IIIb, IV, V) who have received a new generation drug eluting stent.
Not a fit: Patients over 85 years old, those with a high risk of bleeding, or those requiring oral anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized anti-platelet therapy durations, improving safety and efficacy for patients with chronic kidney disease.
How similar studies have performed: Other studies have explored anti-platelet therapy durations, but this specific approach in advanced chronic kidney disease patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 19 years old 2. Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR \<45 / \<30 / \<15 or dialysis) 3. Patients treated with a new generation drug eluting stent. 4. Patients who signed consent form Exclusion Criteria: 1. Over 85 years old 2. Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks 3. Patients who need oral anticoagulant 4. Pregnant women or women of childbearing age 5. Life expectancy is less than 1 year 6. Patients with a history of intracranial bleeding 7. Moderate to severe hepatic impairment (Child-Pugh class B or C)
Where this trial is running
Seoul
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jung-Sun Kim, MD, PhD, FESC — Severance Hospital
- Study coordinator: Jung-Sun Kim, MD, PhD, FESC
- Email: KJS1218@yuhs.ac
- Phone: 82)-2)-2228-8457
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.