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

March 24, 2019 updated by: Litao Zhang, MD, Wuhan Asia Heart Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
        • Principal Investigator:
          • zhang li tao, MD.P

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extend anticoagulation group
Extended the duration anticoauglation to 12 months
Drug: Warfarin Sodium
Extending warfarin anticoagulation
No Intervention: Stop anticoagulation group
Just stop oral anticoagulation like routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombotic events
Time Frame: 24 months
Stroke, DVT, PE, valve thrombosis
24 months
Bleeding events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Asia Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 30, 2021

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 24, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-P-026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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