Anti-coagulation Therapy, Atrial Fibrillation, DVT, Joint Surgery Multiple, Prosthetic Replacement of Mitral Valve, Pulmonary Embolism
Conditions
Keywords
warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin
Brief summary
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to warfarin.
Interventions
DEVICEWarfarin GenoSTAT Test
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Sponsors
Iverson Genetic Diagnostics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women at least 65 years old 2. Beginning warfarin (0 - 3 doses of warfarin taken at the time of enrollment) for a variety of diseases or conditions that require at least 30 days oral anticoagulation with target INR ≥ 2.0
Exclusion criteria
1. Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia) 2. A previous genetically determined warfarin dose 3. The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of warfarin related clinical events | 30 days | To determine if using warfarin-related pharmacogenetic information in calculating warfarin doses will change the incidence of warfarin-related clinical events, including major hemorrhage and thromboembolic events, at 30 days after initial dose, when compared to warfarin doses calculated without pharmacogenetic data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Warfarin Doses | 90 days | Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range) |
| Hemorrhagic Events | 90 days | The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation |
| Minor hemorrhagic events | 90 days | The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation |
| INR Tests | 30 days | Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range) |
| INR tests | 30 days | The percentage of the total INR tests performed in the first 30 days which are out of target range |
| SF-12 | 90 days | The overall, Physical Composite Score (PCS) and Mental Composite Score (MCS) of the SF-12 quality of life questionnaire at 30 days and at 90 days separately after warfarin initiation |
| Prescriber adherence | 30 days | Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin |
| Major thromboembolic events | 90 days | The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for |
Countries
United States
Outcome results
None listed