Clinical trial NCT01305148: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Official title: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anti-coagulation Therapy
DVT
Pulmonary Embolism
Joint Surgery Multiple
Atrial Fibrillation
Prosthetic Replacement of Mitral Valve
Keywords: warfarin
genetic testing
personalized medicine
anti-coagulants
coumadin
Lead sponsor: Iverson Genetic Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 3800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of warfarin related clinical events
timeFrame: 30 days
Secondary outcomes:
measure: INR Tests
timeFrame: 30 days
measure: Warfarin Doses
timeFrame: 90 days
measure: Hemorrhagic Events
timeFrame: 90 days
measure: Minor hemorrhagic events
timeFrame: 90 days
measure: Major thromboembolic events
timeFrame: 90 days
measure: INR tests
timeFrame: 30 days
measure: SF-12
timeFrame: 90 days
measure: Prescriber adherence
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Veterans' Affairs Medical Center
state: Alabama
city: Glendale
country: United States
facility: Cardiovascular Consultants - Thunderbird
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Consultants - Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Orthoarkansas
state: Arkansas
city: Alhambra
country: United States
facility: Comprehensive Cardiovascular Specialists
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Denver
country: United States
facility: Colorado Heart & Vascular
state: Colorado
city: Crestview
country: United States
facility: Okaloosa Heart & Vascular
state: Florida
city: Fort Lauderdale
country: United States
facility: Infinity-Northshore
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Naples
country: United States
facility: Heart Rhythm Specialists
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Cardiology of Atlanta
state: Georgia
city: Decatur
country: United States
facility: Atlanta Heart Group
state: Georgia
city: Riverdale
country: United States
facility: Southern Heart Research Institute
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rockford
country: United States
facility: Rockford Cardiovascular Research Foundation
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation
state: Illinois
city: Anderson
country: United States
facility: Community Hospital Anderson
state: Indiana
city: Evansville
country: United States
facility: St. Mary's
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, PC
state: Indiana
city: Falls River
country: United States
facility: NECCR
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lansing
country: United States
facility: Thoracic and Cardiovascular Institute
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Heart Foundation
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Grand Island
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lincoln
country: United States
facility: Nebraska Heart
state: Nebraska
city: Omaha
country: United States
facility: Alegent
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health Research
state: North Dakota
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Corvallis
country: United States
facility: Corvallis Clinic
state: Oregon
city: Doylestown
country: United States
facility: Central Bucks Cardiology
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Bedford
country: United States
facility: Nexxus Research
state: Texas
city: Plano
country: United States
facility: Legacy Heart Center
state: Texas
city: Temple
country: United States
facility: Scott & White
state: Texas
city: Waco
country: United States
facility: Providence Health Network
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Bellevue
country: United States
facility: Overlake Hospital
state: Washington
city: Ellensburg
country: United States
facility: Family Health Care of Ellensburg
state: Washington
city: Seattle
country: United States
facility: Polyclinic
state: Washington
city: Seattle
country: United States
facility: Swedish Hospital
state: Washington
city: Tacoma
country: United States
facility: Franciscan Research Center
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: Alhambra Hospital
name: An Pang Chieng, MD
role: PRINCIPAL_INVESTIGATOR
References: