A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve

Heart Valve Diseases Clinical Trial

— SYSU-WARFA  

Official title:

Academic Leader，Head of Cardiac Surgery,Principal Investigator, Clinical Professor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01633957
• Other study ID #: SYSU-XZ001
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2012
• Last updated: July 22, 2016
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xi Zhang, MD.
• Phone: 86-13902279690
• Email: zhangxisysu[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anticoagulation Treatment Overdose
• Heart Valve Diseases

Intervention

Other:
• Genotype-based Warfarin Initiation model
Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
• clinical factor-based warfarin initiation model
Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.

Locations

Country	Name	City	State
China	The first affiliated hospital of Sun Yat Sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Xi Zhang	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to steady dosage		from seven days after the operation to thirty days after the operation	Yes
Primary	Time in Therapeutic Range		from five days after the operation to thirty days after the operation	Yes
Secondary	first time to treatment window		from five days after the operation to thirty days after the operation	Yes
Secondary	the ratio of INR=3.0 and INR=1.5		from five days after the operation to thirty days after the operation	Yes
Secondary	the monitoring frequency of INR		30 days after the operation	No
Secondary	the whole-cause mortality		30 days after the operation	Yes
Secondary	major bleeding event		30 days after the operation	Yes
Secondary	major thrombosis rate		30 days after the operation	Yes
Secondary	absolute difference between the stable dose and initial dose		30 days after the operation	No
Secondary	the frequency of dosage change		30 days after the operation	Yes

External Links

•   one of the best warfarin dose model