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

Atrial Fibrillation Clinical Trial

— WARFARIN  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01305148
• Other study ID #: IG-0109
• Status: Suspended
• Phase: N/A
• First received: February 25, 2011
• Last updated: August 27, 2015
• Start date: August 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Iverson Genetic Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 3800
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Device:
• Warfarin GenoSTAT Test
Use of genetic information from the GenoSTAT test to determine the warfarin dose

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Comprehensive Cardiovascular Specialists	Alhambra	California
United States	Community Hospital Anderson	Anderson	Indiana
United States	Mission Hospital	Asheville	North Carolina
United States	Cardiology of Atlanta	Atlanta	Georgia
United States	Grady Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Nexxus Research	Bedford	Texas
United States	Overlake Hospital	Bellevue	Washington
United States	Bend Memorial Clinic	Bend	Oregon
United States	Billings Clinic	Billings	Montana
United States	Veterans' Affairs Medical Center	Birmingham	Alabama
United States	St. Alphonsus Regional Medical Center	Boise	Idaho
United States	Aultman Hospital	Canton	Ohio
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Palmetto Health Richland	Columbia	South Carolina
United States	Corvallis Clinic	Corvallis	Oregon
United States	Okaloosa Heart & Vascular	Crestview	Florida
United States	Atlanta Heart Group	Decatur	Georgia
United States	Colorado Heart & Vascular	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Central Bucks Cardiology	Doylestown	Pennsylvania
United States	Family Health Care of Ellensburg	Ellensburg	Washington
United States	St. Mary's	Evansville	Indiana
United States	NECCR	Falls River	Massachusetts
United States	Sanford Health Research	Fargo	North Dakota
United States	Infinity-Northshore	Fort Lauderdale	Florida
United States	Cardiovascular Consultants - Thunderbird	Glendale	Arizona
United States	Nebraska Heart Institute	Grand Island	Nebraska
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Infinity Clinical Research	Hollywood	Florida
United States	Kansas City Heart Foundation	Kansas City	Missouri
United States	Thoracic and Cardiovascular Institute	Lansing	Michigan
United States	Nebraska Heart	Lincoln	Nebraska
United States	Orthoarkansas	Little Rock	Arkansas
United States	Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Medical Consultants, PC	Muncie	Indiana
United States	Intermountain Medical Center	Murray	Utah
United States	Heart Rhythm Specialists	Naples	Florida
United States	St. Thomas Research Institute	Nashville	Tennessee
United States	Alegent	Omaha	Nebraska
United States	Cardiovascular Consultants - Phoenix	Phoenix	Arizona
United States	Legacy Heart Center	Plano	Texas
United States	Southern Heart Research Institute	Riverdale	Georgia
United States	Carolina Cardiology	Rock Hill	South Carolina
United States	Rockford Cardiovascular Research Foundation	Rockford	Illinois
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Polyclinic	Seattle	Washington
United States	Swedish Hospital	Seattle	Washington
United States	Cox Medical Center	Springfield	Missouri
United States	St. Joseph's Medical Center	Stockton	California
United States	Franciscan Research Center	Tacoma	Washington
United States	Scott & White	Temple	Texas
United States	Carle Foundation	Urbana	Illinois
United States	Providence Health Network	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Iverson Genetic Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days	Yes
Secondary	INR Tests	Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)	30 days	Yes
Secondary	Warfarin Doses	Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)	90 days	No
Secondary	Hemorrhagic Events	The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation	90 days	Yes
Secondary	Minor hemorrhagic events	The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation	90 days	Yes
Secondary	Major thromboembolic events	The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for	90 days	Yes
Secondary	INR tests	The percentage of the total INR tests performed in the first 30 days which are out of target range	30 days	No
Secondary	SF-12	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	90 days	No
Secondary	Prescriber adherence	Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin	30 days	No

External Links

•   WARFARIN Study main website