A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve (SYSU-WARFA)
This study is currently recruiting participants.
Verified July 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
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
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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
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 Overdose Heart Diseases Cardiovascular Diseases Poisoning Substance-Related Disorders |
Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013