Clinical trial NCT01996657: D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Official title: D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Disease
Keywords: mechanical valves replacement
INR
D-dimer
thromboembolic events
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin

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.

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.

Eligibility 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

Primary outcomes:
measure: Bleeding Events;
timeFrame: Up to 24 months
measure: Thrombotic Events
timeFrame: 24 months
Secondary outcomes:
measure: All Cause Deaths
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WAHH
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: zhang zhenlu, PH.D
role: STUDY_DIRECTOR
affiliation: Wuhan Asia Heart Hospital
name: Zhou xin, Doctor
role: STUDY_CHAIR
affiliation: Wuhan Asia Heart Hospital
name: liu ze jin, PH.D
role: STUDY_DIRECTOR
References:
citation: Zhang L, Long Y, Xiao H, Yang J, Liu X, Zhang Z. D-Dimer to Predict the Clinical Outcomes in Patients with Mechanical Heart Valve Replacement During Oral Anticoagulation Therapy. Int Heart J. 2019 May 30;60(3):631-636. doi: 10.1536/ihj.18-237. Epub 2019 Apr 25.
citation: Zhang L, Zheng X, Long Y, Wu M, Chen Y, Yang J, Liu Z, Zhang Z. D-dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial. J Thromb Haemost. 2017 Oct;15(10):1934-1941. doi: 10.1111/jth.13782. Epub 2017 Sep 20.