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

Iverson Genetic Diagnostics, Inc.3,800 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,800

Conditions

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

Interventions

Warfarin GenoSTAT TestDEVICE

Use of genetic information from the GenoSTAT test to determine the warfarin dose

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (56)

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

INR Tests

Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)

Time frame: 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)

Time frame: 90 days

Hemorrhagic Events

The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation

Time frame: 90 days

Minor hemorrhagic events

The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation

Time frame: 90 days

Major thromboembolic events

The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for

Time frame: 90 days

INR tests

The percentage of the total INR tests performed in the first 30 days which are out of target range

Data from ClinicalTrials.gov

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