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Completed

NCT Number: NCT01996657

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

WAHH, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age>18years,male or female without pregnancy;
  • Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
  • 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.

  • deep venous thromboembolism
  • Pulmonary embolism
  • Aortic dissection
  • stroke
  • Cerebral hemorrhage
  • Myocardial infarction

Treatment and study plan

Warfarin

Drug

Other names: Warfarin Sodium Tablets

Primary outcomes

  1. Bleeding Events;

    Time frame: Up to 24 months

    The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.

  2. Thrombotic Events

    Time frame: 24 months

    The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.

Secondary outcomes

  1. All Cause Deaths

    Time frame: Up to 24 months

    The deaths from all causes

Sponsors and collaborators

Lead sponsor

Wuhan Asia Heart Hospital

Other

Registry information

Official study title

D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement

Acronym: 3D-INTENSITY

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2013
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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