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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01996657
Other study ID # 2013-P-002
Secondary ID
Status Completed
Phase N/A
First received November 4, 2013
Last updated May 30, 2016
Start date November 2013
Est. completion date November 2015

Study information

Verified date December 2015
Source Wuhan Asia Heart Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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. 629 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:1.6-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.6-2.6), 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.


Recruitment information / eligibility

Status Completed
Enrollment 730
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 aortic valve replacement and/or Mitral valve replacement .

Exclusion Criteria:

1. deep venous thromboembolism

2. Pulmonary embolism

3. Aortic dissection

4. stroke

5. Cerebral hemorrhage

6. Myocardial infarction

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Warfarin


Locations

Country Name City State
China WAHH Wuhan Hubei
China Wuhan Asia Heart Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thromboembolic Events Thromboembolic Events include venous thromboembolism ,stroke. death Up to 36 months No
Secondary Bleeding Events Up to 36 months No
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