NCT03885180

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

Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Wuhan Asia Heart Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Valve Heart Disease
• Anticoagulants; Increased

Interventions

Type	Name	Description
DRUG	Warfarin Sodium	Extending warfarin anticoagulation

Timeline

• Start date: 2019-03-20
• Primary completion: 2021-03-01
• Completion: 2021-03-30
• First posted: 2019-03-21
• Last updated: 2019-03-26

Locations

1 site across 1 country: China