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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

772 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Warfarin

Intervention Type DRUG

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.

Warfarin

Intervention Type DRUG

Low intensity without adjustment

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

Other Intervention Names

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Warfarin Sodium Tablets

Eligibility Criteria

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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).