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Trial record 14 of 45988 for:    intensity

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

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.


Condition or disease Intervention/treatment
Heart Valve Disease Drug: Warfarin

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.


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Study Type : Observational
Actual Enrollment : 772 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement
Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Drug: Warfarin
Other Name: Warfarin Sodium Tablets

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.
Drug: Warfarin
Other Name: Warfarin Sodium Tablets

Low intensity without adjustment
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Drug: Warfarin
Other Name: Warfarin Sodium Tablets




Primary Outcome Measures :
  1. 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.

  2. Thrombotic Events [ Time Frame: 24 months ]
    The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.


Secondary Outcome Measures :
  1. All Cause Deaths [ Time Frame: Up to 24 months ]
    The deaths from all causes


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin
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

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 ClinicalTrials.gov identifier (NCT number): NCT01996657


Locations
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China, Hubei
WAHH
Wuhan, Hubei, China, 430000
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT01996657     History of Changes
Other Study ID Numbers: 2013-P-002
First Posted: November 27, 2013    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wuhan Asia Heart Hospital:
mechanical valves replacement
INR
D-dimer
thromboembolic events
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Fibrin fragment D
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants