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

Primary Purpose

Valve Heart Disease, Anticoagulants; Increased

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Warfarin Sodium
Sponsored by
Wuhan Asia Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Valve Heart Disease focused on measuring bioprosthetic heart valves, oral anticoagulation, thrombotic events

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wuhan Asia Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Extend anticoagulation group

Stop anticoagulation group

Arm Description

Extended the duration anticoauglation to 12 months

Just stop oral anticoagulation like routine

Outcomes

Primary Outcome Measures

Thrombotic events
Stroke, DVT, PE, valve thrombosis
Bleeding events

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
March 24, 2019
Sponsor
Wuhan Asia Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03885180
Brief Title
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
Acronym
REDUCE
Official Title
Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Asia Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valve Heart Disease, Anticoagulants; Increased
Keywords
bioprosthetic heart valves, oral anticoagulation, thrombotic events

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extend anticoagulation group
Arm Type
Experimental
Arm Description
Extended the duration anticoauglation to 12 months
Arm Title
Stop anticoagulation group
Arm Type
No Intervention
Arm Description
Just stop oral anticoagulation like routine
Intervention Type
Drug
Intervention Name(s)
Warfarin Sodium
Intervention Description
Extending warfarin anticoagulation
Primary Outcome Measure Information:
Title
Thrombotic events
Description
Stroke, DVT, PE, valve thrombosis
Time Frame
24 months
Title
Bleeding events
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang li tao, MD.P
Phone
+86 02765796739
Email
zhangleetau@163.com
First Name & Middle Initial & Last Name & Degree
zhang li tao, MD.P

12. IPD Sharing Statement

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

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