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

NCT07677410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1172

Last updated 2026-08-10

No results posted yet for this study

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

Interventions

DRUG

Aspirin

Aspirin 75-100 mg orally once daily

DRUG

Warfarin

Warfarin orally with dose adjusted to maintain INR 2-3

Sponsors & Collaborators

  • Suzhou Jiecheng Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-18
Primary Completion
2029-07-01
Completion
2030-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677410 on ClinicalTrials.gov