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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xi Zhang, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01633957
First received: June 20, 2012
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Anticoagulation Treatment Overdose
Heart Valve Diseases
Other: Genotype-based Warfarin Initiation model
Other: clinical factor-based warfarin initiation model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Academic Leader,Head of Cardiac Surgery,Principal Investigator, Clinical Professor

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • time to steady dosage [ Time Frame: from seven days after the operation to thirty days after the operation ] [ Designated as safety issue: Yes ]
  • Time in Therapeutic Range [ Time Frame: from five days after the operation to thirty days after the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • first time to treatment window [ Time Frame: from five days after the operation to thirty days after the operation ] [ Designated as safety issue: Yes ]
  • the ratio of INR≥3.0 and INR≤1.5 [ Time Frame: from five days after the operation to thirty days after the operation ] [ Designated as safety issue: Yes ]
  • the monitoring frequency of INR [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ]
  • the whole-cause mortality [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]
  • major bleeding event [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]
  • major thrombosis rate [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]
  • absolute difference between the stable dose and initial dose [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ]
  • the frequency of dosage change [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genotype-based Warfarin Initiation Other: Genotype-based Warfarin Initiation model
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
Active Comparator: clinical factor-based warfarin initiation 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633957

Contacts
Contact: Xi Zhang, Doctor 86-13902279690 zhangxisysu@163.com
Contact: Zhe Xu, Master 86-13828453339 xuzhesums@163.com

Locations
China, Guangdong
The first affiliated hospital of Sun Yat Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xi Zhang, Doctor    86-13902279690    zhangxisysu@163.com   
Contact: Zhe Xu, Master    86-13828453339    xuzhesums@163.com   
Sub-Investigator: Zhe Xu, Master         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
  More Information

Additional Information:
No publications provided

Responsible Party: Xi Zhang, Head of cardiac surgery, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01633957     History of Changes
Other Study ID Numbers: SYSU-XZ001
Study First Received: June 20, 2012
Last Updated: July 5, 2012
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
anticoagulation
bleeding
CYP2C9
CYP4F2
VKORC1
warfarin dosing
Heart Valve Diseases
pharmacogenomics

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014