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

Not Applicable

Suspended

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

• Registration Number: NCT01305148
• Lead Sponsor: Iverson Genetic Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Study Start: 2011-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-31
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 3800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Minor hemorrhagic events	90 days	The number of minor hemorrhagic adverse events at 30, 60 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
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
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
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)
Major thromboembolic events	90 days	The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for

Trial Locations

Locations (56)

Veterans' Affairs Medical Center; 🇺🇸 Birmingham, Alabama, United States

Cardiovascular Consultants - Thunderbird; 🇺🇸 Glendale, Arizona, United States

Cardiovascular Consultants - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Orthoarkansas; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive Cardiovascular Specialists; 🇺🇸 Alhambra, California, United States

St. Joseph's Medical Center; 🇺🇸 Stockton, California, United States

Colorado Heart & Vascular; 🇺🇸 Denver, Colorado, United States

Okaloosa Heart & Vascular; 🇺🇸 Crestview, Florida, United States

Infinity-Northshore; 🇺🇸 Fort Lauderdale, Florida, United States

Infinity Clinical Research; 🇺🇸 Hollywood, Florida, United States

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