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

NCT ID: NCT01305148

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

3800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-12-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Warfarin GenoSTAT Test

Intervention Type DEVICE

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Warfarin GenoSTAT Test

Intervention Type DEVICE

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

Interventions

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Warfarin GenoSTAT Test

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

Intervention Type DEVICE

Other Intervention Names

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Warfarin GenoSTAT pharmacogenetic testing personalized medicine

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iverson Genetic Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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An Pang Chieng, MD

Role: PRINCIPAL_INVESTIGATOR

Alhambra Hospital

Locations

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Veterans' Affairs Medical Center

Birmingham, Alabama, United States

Site Status

Cardiovascular Consultants - Thunderbird

Glendale, Arizona, United States

Site Status

Cardiovascular Consultants - Phoenix

Phoenix, Arizona, United States

Site Status

Orthoarkansas

Little Rock, Arkansas, United States

Site Status

Comprehensive Cardiovascular Specialists

Alhambra, California, United States

Site Status

St. Joseph's Medical Center

Stockton, California, United States

Site Status

Colorado Heart & Vascular

Denver, Colorado, United States

Site Status

Okaloosa Heart & Vascular

Crestview, Florida, United States

Site Status

Infinity-Northshore

Fort Lauderdale, Florida, United States

Site Status

Infinity Clinical Research

Hollywood, Florida, United States

Site Status

Heart Rhythm Specialists

Naples, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

Grady Hospital

Atlanta, Georgia, United States

Site Status

Cardiology of Atlanta

Atlanta, Georgia, United States

Site Status

Atlanta Heart Group

Decatur, Georgia, United States

Site Status

Southern Heart Research Institute

Riverdale, Georgia, United States

Site Status

St. Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Rockford Cardiovascular Research Foundation

Rockford, Illinois, United States

Site Status

Carle Foundation

Urbana, Illinois, United States

Site Status

Community Hospital Anderson

Anderson, Indiana, United States

Site Status

St. Mary's

Evansville, Indiana, United States

Site Status

Medical Consultants, PC

Muncie, Indiana, United States

Site Status

NECCR

Falls River, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Thoracic and Cardiovascular Institute

Lansing, Michigan, United States

Site Status

Kansas City Heart Foundation

Kansas City, Missouri, United States

Site Status

Cox Medical Center

Springfield, Missouri, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Nebraska Heart Institute

Grand Island, Nebraska, United States

Site Status

Nebraska Heart

Lincoln, Nebraska, United States

Site Status

Alegent

Omaha, Nebraska, United States

Site Status

Hackensack Medical Center

Hackensack, New Jersey, United States

Site Status

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Site Status

Mission Hospital

Asheville, North Carolina, United States

Site Status

Sanford Health Research

Fargo, North Dakota, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Bend Memorial Clinic

Bend, Oregon, United States

Site Status

Corvallis Clinic

Corvallis, Oregon, United States

Site Status

Central Bucks Cardiology

Doylestown, Pennsylvania, United States

Site Status

Palmetto Health Richland

Columbia, South Carolina, United States

Site Status

Carolina Cardiology

Rock Hill, South Carolina, United States

Site Status

St. Thomas Research Institute

Nashville, Tennessee, United States

Site Status

Texas Cardiac Arrhythmia

Austin, Texas, United States

Site Status

Nexxus Research

Bedford, Texas, United States

Site Status

Legacy Heart Center

Plano, Texas, United States

Site Status

Scott & White

Temple, Texas, United States

Site Status

Providence Health Network

Waco, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Overlake Hospital

Bellevue, Washington, United States

Site Status

Family Health Care of Ellensburg

Ellensburg, Washington, United States

Site Status

Polyclinic

Seattle, Washington, United States

Site Status

Swedish Hospital

Seattle, Washington, United States

Site Status

Franciscan Research Center

Tacoma, Washington, United States

Site Status

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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IG-0109

Identifier Type: -

Identifier Source: org_study_id

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