Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy (REDUCE)

Wuhan Asia Heart Hospital

Status: Unknown

Conditions: Anticoagulants; Increased; Valve Heart Disease

Treatments: Drug: Warfarin Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03885180

2019-P-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Extend anticoagulation group

Experimental group

Description:

Extended the duration anticoauglation to 12 months

Treatment:

Drug: Warfarin Sodium

Stop anticoagulation group

No Intervention group

Description:

Just stop oral anticoagulation like routine