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NCT05375474

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

Status unknown Phase 4 Last updated 23 October 2023
What this trial tests

Phase 4 trial testing Oral anticoagulation therapy in Transcatheter Aortic Valve Replacement in 650 participants. Status unknown.

Timeline
27 July 2023
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorChina National Center for Cardiovascular Diseases
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment650
Start date27 July 2023
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

China National Center for Cardiovascular Diseases — full company profile →

Who can join

Adults 18 to 85, any sex, with Transcatheter Aortic Valve Replacement or Antithrombotic Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Hu X, Xu H, Wang C, Wang Y, et al · · 2023 · cited 1× · PMID 37989381 · DOI 10.1136/bmjopen-2023-076781

Verify or expand the search:

Other trials of Oral anticoagulation therapy

Trials testing the same drug.

Other recruiting trials for Transcatheter Aortic Valve Replacement

Currently open trials in the same condition.

Other China National Center for Cardiovascular Diseases trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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