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

NCT01996657 | Completed Results DMC

• 1 other identifier: 2013-P-002
• Study Type: observational
• Target: 772
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Valve Disease

Keywords

mechanical valves replacement; INR; D-dimer; thromboembolic events

Outcome Measures

Primary Outcomes (2)

• Bleeding Events;

  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.

  Up to 24 months

• Thrombotic Events

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

  24 months

Secondary Outcomes (1)

• All Cause Deaths

  Up to 24 months

Study Arms (3)

Standard intensity of anticoagulation

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).

Drug: Warfarin

Low intensity and adjusted by elevated D-dimer

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.

Drug: Warfarin

Low intensity without adjustment

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

Drug: Warfarin

Interventions

Warfarin DRUG

Also known as: Warfarin Sodium Tablets

Low intensity and adjusted by elevated D-dimer; Low intensity without adjustment; Standard intensity of anticoagulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Wuhan Asia Heart Hospital: lead

Study Sites (2)

WAHH

Wuhan, Hubei, 430000, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (2)

• 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.

  PMID: 31019170 DERIVED

• 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.

  PMID: 28762606 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart Valve Diseases; Thromboembolism

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr.Litao Zhang
• Organization: Wuhan Asia Heart Hospital

zhengleetau@qq.com

+862765796888

Study Officials

• zhang zhenlu, PH.D

  Wuhan Asia Heart Hospital

  STUDY DIRECTOR

• Zhou xin, Doctor

  Wuhan Asia Heart Hospital

  STUDY CHAIR

• liu ze jin, PH.D

  Wuhan Asia Heart Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2016-06

Locations

CN (2)