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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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Fuwai hospital
Beijing, Beijing Municipality, China
Start Date
July 27, 2023
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
October 23, 2023
650
ESTIMATED participants
Oral anticoagulation therapy
DRUG
Single antiplatelet therapy
DRUG
Lead Sponsor
China National Center for Cardiovascular Diseases
NCT06518317
NCT04139616
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05202977