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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus double antiplatelet therapy (DAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the DAPT group (aspirin and clopidogrel) 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 prosthetic valve thrombosis diagnosed by 4D-CT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases

Criteria

Inclusion Criteria:

• Successful TAVR (VARC 3)

• Self-expanding prosthetic valve

• Written informed consent provided

Exclusion Criteria:

• patients with indications for anticoagulation therapy, such as atrial fibrillation;

• patients with indications for double antiplatelet therapy, such as myocardial infarction within 1 year, percutaneous coronary intervention within 6 months, or peripheral artery stent implantation within 3 months;

• patients need concomitant PCI during the index hospitalization;

• patients with peptic ulcers or active bleeding;

• patients with ischemic stroke or TIA within 6 months;

• patients with a history of cerebral hemorrhage;

• patients allergic to aspirin, clopidogrel, or Vitamin-K antagonists;

• patients with creatinine clearance rate<15ml/min (Cockcroft formula) or need dialysis;

• patients' life expectancy less than 1 year;

• patients who already participated in other clinical trials.