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

Iverson Genetic Diagnostics

Status: Suspended

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

Treatments: Device: Warfarin GenoSTAT Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305148

IG-0109

Details and patient eligibility

About

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.

Enrollment: 3,800 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,800 participants in 3 patient groups

Randomized - Genetic

Experimental group

Description:

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

Treatment:

Device: Warfarin GenoSTAT Test

Randomized - Clinical

No Intervention group

Description:

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

Experimental group

Description:

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

Treatment:

Device: Warfarin GenoSTAT Test