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A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve (SYSU-WARFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01633957
Recruitment Status : Unknown
Verified July 2016 by Xi Zhang, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : July 6, 2012
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Xi Zhang, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE June 20, 2012
First Posted Date  ICMJE July 6, 2012
Last Update Posted Date July 25, 2016
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • time to steady dosage [ Time Frame: from seven days after the operation to thirty days after the operation ]
  • Time in Therapeutic Range [ Time Frame: from five days after the operation to thirty days after the operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
  • first time to treatment window [ Time Frame: from five days after the operation to thirty days after the operation ]
  • the ratio of INR≥3.0 and INR≤1.5 [ Time Frame: from five days after the operation to thirty days after the operation ]
  • the monitoring frequency of INR [ Time Frame: 30 days after the operation ]
  • the whole-cause mortality [ Time Frame: 30 days after the operation ]
  • major bleeding event [ Time Frame: 30 days after the operation ]
  • major thrombosis rate [ Time Frame: 30 days after the operation ]
  • absolute difference between the stable dose and initial dose [ Time Frame: 30 days after the operation ]
  • the frequency of dosage change [ Time Frame: 30 days after the operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
Official Title  ICMJE Academic Leader,Head of Cardiac Surgery,Principal Investigator, Clinical Professor
Brief Summary

Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.

Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Anticoagulation Treatment Overdose
  • Heart Valve Diseases
Intervention  ICMJE
  • Other: Genotype-based Warfarin Initiation model
    Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
  • Other: clinical factor-based warfarin initiation model
    Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
Study Arms  ICMJE
  • Experimental: Genotype-based Warfarin Initiation
    Intervention: Other: Genotype-based Warfarin Initiation model
  • Active Comparator: clinical factor-based warfarin initiation
    Intervention: Other: clinical factor-based warfarin initiation model
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 5, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
  • willing to join in the clinical trial and comply with the protocol.

Exclusion Criteria:

  • other ethnic groups than Han
  • previously receive any other cardiac surgery
  • emergent surgery
  • simultaneously carry out other cardiac surgeries,such as CABG
  • age younger than 18y or older than 65 year
  • drug abuser and wine abuser
  • any malignancy
  • moderate or severe hepatic or kidney insufficiency
  • any thyroid disease
  • the history of warfarin or VitK consumption 2 week before the surgery
  • any hematological disease or history of bleeding
  • combination with any drugs that significantly influence warfarin other than Cordarone
  • pregnancy
  • any contraindication of warfarin
  • infectious endocarditis
  • advanced valvular disease
  • pathological obesity
  • psychological disease
  • any patient having joined in other clinical trial in the previous 30d
  • basic INR > 1.4
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633957
Other Study ID Numbers  ICMJE SYSU-XZ001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xi Zhang, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Xi Zhang
Collaborators  ICMJE Sun Yat-sen University
Investigators  ICMJE
Study Director: Xi Zhang, MD. First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Zhe Xu, MD.,PHD. First Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP