D-dimer and Oral Anticoagulation Therapy in Patients With Mechanical Valve Replacement

Heart Valve Disease Clinical Trial

— 3D-intensity  

Official title:

D-dimer Levels Determined the Intensity of Oral Anticoagulation in Patients With Mechanical Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996657
• Other study ID #: 2013-P-002
• 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

• Heart Valve Disease
• Heart Valve Diseases

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