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NCT03885180 Clinical Trial

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

Valve Heart Disease Clinical Trial

— REDUCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03885180
Other study ID # 2019-P-026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2019
Est. completion date March 30, 2021

Study information
Verified date March 2019
Source Wuhan Asia Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 30, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Warfarin Sodium
Extending warfarin anticoagulation

Locations
Country Name City State
China Wuhan Asia Heart Hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Thrombotic events Stroke, DVT, PE, valve thrombosis 24 months
Primary Bleeding events 24 months
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