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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Patients aged 18-85 years old with severe aortic stenosis;

• Successful TAVR via femoral artery approach (VARC 3 device success criteria);

• Implantation of self-expanding bioprosthetic valve;

• Be willing to give informed consent.

Locations
Other Locations
China
Fuwai hospital
RECRUITING
Beijing
Contact Information
Primary
Yongjian Wu, MD,PhD
yongjianwu_nccd@163.com
+86 13701387189
Backup
Yunqing Ye, Master
judia8510@163.com
+86 13699282532
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 650
Treatments
Experimental: Oral anticoagulation therapy group
Vitamin-K antagonists (warfarin), therapeutic INR: 1.8-2.5
Active_comparator: Single antiplatelet therapy group
Aspirin, 75-100mg
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov

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