Aspirin by itself after TAVR for pure aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial compares two antithrombotic strategies after TAVR in patients with pure aortic regurgitation. Participants are randomly assigned to aspirin 75-100 mg daily for 12 months or warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. The primary outcome is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 12 months. The study aims to enroll 1,172 participants with follow-ups at 30 days, 6 months, and 12 months. The trial operates under VARC-3 criteria for AR-specific device success and excludes those with indications for long-term anticoagulation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years.
* Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).
* Trileaflet aortic valve anatomy.
* No long-term anticoagulation indication (including but not limited to: atrial fibrillation, mechanical mitral valve prosthesis, deep vein thrombosis, pulmonary embolism, left ventricular thrombus, pulmonary hypertension, or coagulation disorders) as confirmed by the investigator.
* Signed written informed consent and willingness to comply with randomization, study procedures, and follow-up.

Exclusion Criteria:

* Need for oral anticoagulation or dual antiplatelet therapy, or need for oral or intravenous strong CYP3A inhibitors that cannot be paused during the study period.
* Active pathological bleeding, subdural hematoma, or history of intracranial hemorrhage.
* Ischemic stroke within 30 days before TAVR.
* Acute myocardial infarction within 30 days.
* Severe hepatic insufficiency (cirrhosis, hepatic decompensation).
* Severe renal insufficiency (eGFR \< 30 mL/min/1.73 m²) or need for renal replacement therapy.
* Stent implantation (including coronary, carotid, or peripheral arteries) within 12 months before TAVR, or planned stent implantation within 1 year after TAVR.
* Coronary artery bypass grafting (CABG) within 12 months before TAVR.
* Allergy, intolerance, or known resistance to aspirin, clopidogrel, or warfarin.
* Known coagulation disorders or bleeding diathesis (including but not limited to platelet count ≤50,000/mm³ at screening).
* Any contraindication to anticoagulation therapy.
* Prior aortic valve prosthesis (mechanical or bioprosthetic); mitral valve bioprosthesis replacement within 1 year before TAVR; or prior mitral mechanical valve replacement; or prior tricuspid valve replacement.
* Emergency TAVR with cardiogenic shock manifesting as low cardiac output, vasopressor or respiratory dependence, or mechanical hemodynamic support.
* Life expectancy \<1 year (e.g., terminal malignancy).
* Participation in another investigational drug or device clinical study (patients who have completed the primary endpoint of the study and are currently in long-term follow-up are not excluded).
* Pregnancy or planned pregnancy, or use of estrogen or estrogen-like drugs (for women with suspected pregnancy, serum or urine human chorionic gonadotropin test must be negative before enrollment).
* Any other condition deemed by the investigator to be inappropriate for study participation.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lai Wei, MD
• Email: Wei.lai@zs-hospital.sh.cn
• Phone: +86-021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.