Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Wuhan Asia Heart Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Thrombotic events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Extend anticoagulation group
Extended the duration anticoauglation to 12 months
Intervention: Warfarin Sodium (Drug)
Outcomes
Primary Outcomes
Thrombotic events
Time Frame: 24 months
Stroke, DVT, PE, valve thrombosis
Bleeding events
Time Frame: 24 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Litao Zhang, MD
Head of anticoagulation clinic
Wuhan Asia Heart Hospital