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D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement (3D-INTENSITY)

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ClinicalTrials.gov Identifier: NCT01996657
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

Tracking Information
First Submitted Date November 4, 2013
First Posted Date November 27, 2013
Results First Submitted Date April 9, 2017
Results First Posted Date June 26, 2017
Last Update Posted Date June 26, 2017
Study Start Date January 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2017)
  • Bleeding Events; [ Time Frame: Up to 24 months ]
    The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
  • Thrombotic Events [ Time Frame: 24 months ]
    The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Original Primary Outcome Measures
 (submitted: November 21, 2013)
Thromboembolic Events [ Time Frame: Up to 24 months ]
Thromboembolic Events include venous thromboembolism ,stroke.
Change History
Current Secondary Outcome Measures
 (submitted: April 9, 2017)
All Cause Deaths [ Time Frame: Up to 24 months ]
The deaths from all causes
Original Secondary Outcome Measures
 (submitted: November 21, 2013)
Vascular Events [ Time Frame: Up to 24 months ]
Vascular Events include Cerebral hemorrhage,myocardial infarction ,Cardiac death,Unexplained death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Official Title D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement
Brief Summary

The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Detailed Description

Background: The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

Objective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Methods: A single-center, prospective study was performed. 748 Patients with mechanical valve replacement who had received oral anticoagulation. The patients were randomly assigned to three groups The intensity of anticoagulation for group one was standard intensity (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times at 3 month later. In case of D-dimer level elevated, adjusted the intensity of anticoagulation to standard level. The endpoint of the study was the subsequent thromboembolic and major bleeding during an average follow-up of 2 years.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin
Condition Heart Valve Disease
Intervention Drug: Warfarin
Other Name: Warfarin Sodium Tablets
Study Groups/Cohorts
  • Standard intensity of anticoagulation
    After mechanical valve replacement,patients should be gave oral anticoagulants,such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
    Intervention: Drug: Warfarin
  • Low intensity and adjusted by elevated D-dimer
    The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
    Intervention: Drug: Warfarin
  • Low intensity without adjustment
    The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
    Intervention: Drug: Warfarin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 9, 2017)
772
Original Estimated Enrollment
 (submitted: November 21, 2013)
500
Actual Study Completion Date June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. age>18years,male or female without pregnancy;
  2. Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
  3. The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).

Exclusion Criteria: Patients with following diseases within 3 months.

  1. deep venous thromboembolism
  2. Pulmonary embolism
  3. Aortic dissection
  4. stroke
  5. Cerebral hemorrhage
  6. Myocardial infarction
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01996657
Other Study ID Numbers 2013-P-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Wuhan Asia Heart Hospital
Study Sponsor Wuhan Asia Heart Hospital
Collaborators Not Provided
Investigators
Study Director: zhang zhenlu, PH.D Wuhan Asia Heart Hospital
Study Chair: Zhou xin, Doctor Wuhan Asia Heart Hospital
Study Director: liu ze jin, PH.D Wuhan Asia Heart Hospital
PRS Account Wuhan Asia Heart Hospital
Verification Date June 2016