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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03885180
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Litao Zhang, MD, Wuhan Asia Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Valve Heart Disease Anticoagulants; Increased Drug: Warfarin Sodium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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

Primary Outcome Measures :
  1. Thrombotic events [ Time Frame: 24 months ]
    Stroke, DVT, PE, valve thrombosis

  2. Bleeding events [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03885180

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China, Hubei
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: zhang li tao, MD.P    +86 02765796739   
Principal Investigator: zhang li tao, MD.P         
Sponsors and Collaborators
Wuhan Asia Heart Hospital
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Responsible Party: Litao Zhang, MD, Head of anticoagulation clinic, Wuhan Asia Heart Hospital Identifier: NCT03885180    
Other Study ID Numbers: 2019-P-026
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Litao Zhang, MD, Wuhan Asia Heart Hospital:
bioprosthetic heart valves
oral anticoagulation
thrombotic events
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases