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

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.

Timeline

Start

2023-07-27

Primary completion

2025-12-31

Completion

2025-12-31

Publications

• Hu X, Xu H, Wang C, Wang Y, Wang Y, Zhou D, Zhu Q, Xu K, Yang J, Zhang H, Jiang N, Zhang J, Fang Z, Fu G, Guo Y, Li Y, Wang M, Feng D, Niu G, Zhang E, Chen Y, Ye Y, Wu Y. Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial. BMJ Open. 2023 Nov 21;13(11):e076781. doi: 10.1136/bmjopen-2023-076781.

Drugs

Indications

No indication recorded.