NCT05375474

Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.

Conditions

• Transcatheter Aortic Valve Replacement
• Antithrombotic Therapy
• Bioprosthetic Valve Thrombosis

Interventions

Type	Name	Description
DRUG	Oral anticoagulation therapy	Vitamin-K antagonists (warfarin)
DRUG	Single antiplatelet therapy	Aspirin

Timeline

• Start date: 2023-07-27
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-05-16
• Last updated: 2023-10-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study