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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03885180
Acronym
REDUCE
Enrollment
500
Registered
2019-03-21
Start date
2019-03-20
Completion date
2021-03-30
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valve Heart Disease, Anticoagulants; Increased

Keywords

bioprosthetic heart valves, oral anticoagulation, thrombotic events

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.

Interventions

Extending warfarin anticoagulation

Sponsors

Wuhan Asia Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Thrombotic events24 monthsStroke, DVT, PE, valve thrombosis
Bleeding events24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026