Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

Study Overview
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Brief Summary
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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.

Official Title
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Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

Conditions
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Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple, Atrial Fibrillation, Prosthetic Replacement of Mitral Valve

Intervention / Treatment
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* Device: Warfarin GenoSTAT Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized - Genetic<br>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 | Device: Warfarin GenoSTAT Test<br>* Use of genetic information from the GenoSTAT test to determine the warfarin dose<br>* Other names: personalized medicine;|
| No Intervention: Randomized - Clinical<br>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 | |
| Experimental: Registry<br>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 | Device: Warfarin GenoSTAT Test<br>* Use of genetic information from the GenoSTAT test to determine the warfarin dose<br>* Other names: personalized medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of warfarin related clinical events | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR Tests | Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range) | 30 days | 
| Warfarin Doses | Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range) | 90 days | 
| Hemorrhagic Events | The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation | 90 days | 
| Minor hemorrhagic events | The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation | 90 days | 
| Major thromboembolic events | The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for | 90 days | 
| INR tests | The percentage of the total INR tests performed in the first 30 days which are out of target range | 30 days | 
| SF-12 | 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 | 90 days | 
| Prescriber adherence | Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin