Genotype-Based Warfarin Therapy (GENWAT) study
Not Applicable
- Conditions
- Atrial fibrillation
- Registration Number
- JPRN-UMIN000006794
- Lead Sponsor
- RIKE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with a history of hypersensitivity to warfarin 2) Pregnancy and lactation patients 3) Patients with severe renal failure (serum creatinine>=2.5 mg/dL, patients on hemodialysis) 4) Patients with cirrhosis 5) Patients with hypoproteinemia (serum albumin<=2.5 g/dL) 6) Patients who require special attention for dosage adjustment 7) Patients with bleeding and who are potentially bleeding 8) Patient who are incapable to understand the contents of this study and will not give informed consent 9) Patients who participate in other clinical studies 10) Patients judged by investigators as ineligible for study enrollment 11) Patients who require invasive treatment during this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Efficacy i) Proportion of patients reaching therapeutic INR range (1.6 to 2.5) at week 2, 4 and 8 ii) Time to the therapeutic INR range 2) Safety i) Bleeding (hematoma, hemorrhage in CNS, GI, GU, pulmonary/upper respiratory, petechiae/purpura, other hemorrhage) ii) Thromboembolism (cerebral embolism, cardiac thrombosis, pulmonary embolism, deep vein thrombosis) iii) INR>=4 iv) Discontinuation of warfarin due to inhibition of coagulation v) Use of Vitamin K medication
- Secondary Outcome Measures
Name Time Method 1) Efficacy i) Total number of dose adjustments for reaching therapeutic INR range ii) Total number of INR measurements for reaching therapeutic INR range iii) Differences between initial and maintenance dosages