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

Not Applicable

• Conditions: Anticoagulation Treatment Overdose; Heart Valve Diseases
• Interventions: Other: clinical factor-based warfarin initiation model; Other: Genotype-based Warfarin Initiation model

• Registration Number: NCT01633957
• Lead Sponsor: Xi Zhang

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 available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-22
• Last Update Posted: 2016-07-25
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clinical factor-based warfarin initiation	clinical factor-based warfarin initiation model	-
Genotype-based Warfarin Initiation	Genotype-based Warfarin Initiation model	-

Primary Outcome Measures

Name	Time	Method
Time in Therapeutic Range	from five days after the operation to thirty days after the operation
time to steady dosage	from seven days after the operation to thirty days after the operation

Secondary Outcome Measures

Name	Time	Method
first time to treatment window	from five days after the operation to thirty days after the operation
the ratio of INR≥3.0 and INR≤1.5	from five days after the operation to thirty days after the operation
absolute difference between the stable dose and initial dose	30 days after the operation
the frequency of dosage change	30 days after the operation
the whole-cause mortality	30 days after the operation
major thrombosis rate	30 days after the operation
the monitoring frequency of INR	30 days after the operation
major bleeding event	30 days after the operation

Trial Locations

Locations (1)

The first affiliated hospital of Sun Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China