Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy

Not Applicable

• Conditions: Valve Heart Disease; Anticoagulants; Increased
• Interventions: Drug: Warfarin Sodium

• Registration Number: NCT03885180
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.

Detailed Description

Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-19
• Study Start: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Submitted: 2019-03-24
• Last Update Posted: 2019-03-26
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients received BHV within 3 months

Exclusion Criteria

• Recently throboemblism within 6 months
• Recently bleedings within 3 months
• Evaluated lifetime less than 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extend anticoagulation group	Warfarin Sodium	Extended the duration anticoauglation to 12 months

Primary Outcome Measures

Name	Time	Method
Thrombotic events	24 months	Stroke, DVT, PE, valve thrombosis
Bleeding events	24 months

Trial Locations

Locations (1)

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China