Comparing aspirin and clopidogrel after heart valve replacement
Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial
This study is testing whether taking aspirin or clopidogrel alone after heart valve replacement helps prevent blood clots in patients with severe aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05493657 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the best antithrombotic therapy following transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis. It is a prospective, multicenter, open-label, randomized controlled trial where eligible patients will be assigned to receive either aspirin or clopidogrel monotherapy after an initial period of dual antiplatelet therapy. The primary focus is to assess the incidence of leaflet thrombosis using cardiac CT and echocardiography at three months post-TAVR. Patients will be monitored clinically for six months to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients over 19 years old who have undergone TAVR for symptomatic severe aortic stenosis.
Not a fit: Patients requiring prolonged dual antiplatelet therapy or those with contraindications to aspirin or clopidogrel may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize post-TAVR antithrombotic therapy, potentially reducing the risk of leaflet thrombosis and improving patient outcomes.
How similar studies have performed: Previous studies have explored antithrombotic therapies in similar contexts, but this specific comparison of aspirin versus clopidogrel post-TAVR is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients \>19 years old 2. Patients who underwent TAVR symptomatic severe AS 3. Provision of informed consent Exclusion Criteria: 1. Patients requiring dual antiplatelet therapy longer than 4 weeks 2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel 3. History of stroke or transient ischemic attack (TIA) within 6 months 4. Planned major surgery 5. Cardiogenic shock or hemodynamic instability 6. Chronic kidney disease stage 4 or 5 (eGFR \<30mL/min) 7. Valve-in-valve TAVR procedure 8. Hypersensitivity or contraindication to aspirin or clopidogrel 9. Indication for anticoagulation therapy
Where this trial is running
Seoul
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Young-Guk Ko, MD, PhD — Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
- Study coordinator: Young-Guk Ko, MD, PhD
- Email: ygko@yuhs.ac
- Phone: 82-2-2228-8460
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.