Actively Recruiting
Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial
Led by Yonsei University · Updated on 2026-01-07
254
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) to find the best single antiplatelet therapy to prevent leaflet thrombosis after the procedure. This trial compares aspirin and clopidogrel monotherapy following an initial 4-week period of dual antiplatelet therapy. The study is designed as a prospective, multicenter, open-label, randomized controlled trial to evaluate the preventive effects of these treatments on leaflet thrombosis. All participants initially receive dual antiplatelet therapy with aspirin 100 mg and clopidogrel 75 mg daily for 4 weeks after TAVR. Then, they are randomly assigned to continue with either aspirin 100 mg daily or clopidogrel 75 mg daily as single antiplatelet therapy. Leaflet thrombosis is assessed at 3 months post-TAVR using cardiac computed tomography (CT) and transthoracic echocardiography. Clinical follow-up continues for up to 6 months to monitor outcomes. Participants will undergo cardiac CT and echocardiography at 3 months to measure leaflet thrombosis and heart valve function. Researchers also track strokes, transient ischemic attacks, thromboembolic events, bleeding events, and other echocardiographic parameters during the 6-month follow-up. The main outcome is the incidence of leaflet thrombosis at 3 months. The study aims to provide important information about the best antiplatelet therapy approach after TAVR.
CONDITIONS
Brief Title
Aspirin vs Clopidogrel After TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 19 years old or older
- Patients who underwent transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis
- Provision of informed consent
You will not qualify if you...
- Patients requiring dual antiplatelet therapy longer than 4 weeks
- Any condition requiring specific antiplatelet therapy with aspirin or clopidogrel
- History of stroke or transient ischemic attack (TIA) within the past 6 months
- Planned major surgery
- Cardiogenic shock or hemodynamic instability
- Chronic kidney disease stage 4 or 5 with eGFR less than 30 mL/min
- Valve-in-valve TAVR procedure
- Hypersensitivity or contraindication to aspirin or clopidogrel
- Indication for anticoagulation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo transcatheter aortic valve replacement (TAVR) followed by 4 weeks of dual antiplatelet therapy with aspirin and clopidogrel, then continue with single antiplatelet therapy of either aspirin or clopidogrel.
1 baseline visit at TAVR, cardiac CT and echocardiography at 3 months, and clinical follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
Y
Young-Guk Ko, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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