Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Enrollment
- 3,800
- Locations
- 56
- Primary Endpoint
- Incidence of warfarin related clinical events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women at least 65 years old
- •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
- •Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- •A previous genetically determined warfarin dose
- •The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
Arms & Interventions
Randomized - Genetic
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
Intervention: Warfarin GenoSTAT Test (Device)
Randomized - Clinical
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from clinical information alone through the warfarindosing.org website
Registry
Subjects who are followed 30 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
Intervention: Warfarin GenoSTAT Test (Device)
Outcomes
Primary Outcomes
Incidence of warfarin related clinical events
Time Frame: 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 Outcomes
- Minor hemorrhagic events(90 days)
- Prescriber adherence(30 days)
- Warfarin Doses(90 days)
- Hemorrhagic Events(90 days)
- INR tests(30 days)
- SF-12(90 days)
- INR Tests(30 days)
- Major thromboembolic events(90 days)