Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation

NCT07677410 | Not Yet Recruiting

• 1 other identifier: KY2026134
• Study Type: interventional
• Target: 1,172
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death/thrombosis. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 months.

Conditions

Aortic Regurgitation Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Non-hierarchical Composite Endpoint

  The primary endpoint is a non-hierarchical composite endpoint including all-cause death, stroke, prosthetic valve thrombosis, intracardiac thrombosis, myocardial infarction, deep vein thrombosis or pulmonary embolism, systemic embolism, and life-threatening, disabling, or major bleeding (VARC-3 definition).

  12 months post-procedure

Secondary Outcomes (16)

• Number of Participants Who Experienced Composite Endpoint of All-Cause Death, Ischemic Stroke, Valve/Intracardiac Thrombosis, and Myocardial Infarction.

  12 months post-procedure

• Number of Participants Who Experienced Composite of Life-threatening, Disabling, or Major Bleeding (based on VARC-3 criteria Type 2-4)

  12 months post-procedure

• Number of Participants Who Experience Composite of Cardiovascular Death, Major Bleeding, Stroke, and Myocardial Infarction

  12 months post-procedure

• Number of Participants Who Experience Clinical Efficacy Composite Endpoint

  12 months post-procedure

• Number of Participants Who Experienced All-Cause Death

  12 months post-procedure

Study Arms (2)

Aspirin Monotherapy

EXPERIMENTAL

Aspirin 75-100 mg orally once daily for 12 months

Drug: Aspirin

Standard Therapy

ACTIVE COMPARATOR

Warfarin (INR 2-3) for 6 months, followed by Aspirin 75-100 mg once daily for 6 months

Drug: Aspirin; Drug: Warfarin

Interventions

Aspirin DRUG

Aspirin 75-100 mg orally once daily

Aspirin Monotherapy; Standard Therapy

Warfarin DRUG

Warfarin orally with dose adjusted to maintain INR 2-3

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Suzhou Jiecheng Medical Technology Co., Ltd.: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

Aspirin; Warfarin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Lai Wei, MD

CONTACT

+86-021-64041990; Wei.lai@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental Group: Aspirin 75-100 mg qd × 12 months Control (Standard) Group：Warfarin (INR 2-3) × 6 months, then aspirin 75-100 mg qd × 6 months

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)