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

Wuhan Asia Heart Hospital

Status: Completed

Conditions: Heart Valve Disease

Treatments: Drug: Warfarin

Study type: Observational

Funder types: Other

Identifiers

NCT01996657

2013-P-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 772 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

772 participants in 3 patient groups

Standard intensity of anticoagulation

Description:

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).

Treatment:

Drug: Warfarin

Low intensity and adjusted by elevated D-dimer

Description:

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.

Treatment:

Drug: Warfarin

Low intensity without adjustment

Description:

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

Treatment:

Drug: Warfarin