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Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT

This study is currently recruiting participants.
Verified August 2011 by Washington University School of Medicine
Sponsor:
Collaborators:
Intermountain Health Care, Inc.
University of Utah
Hospital for Special Surgery, New York
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01006733
First received: October 30, 2009
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

On September 15, 2008, Acting Surgeon General Steven Galson, MD, MPH noted that blood clots contribute to the death of at least 100,000 Americans each year. Because many of these deaths occur suddenly where treatment is impossible, the best treatment is prevention. In this grant, researchers in Missouri, Utah, and NY develop strategies to improve the safety and effectiveness of clot prevention by customizing blood thinners to each person's genetic and clinical profile. They hypothesize that the use of genetics to guide warfarin therapy will reduce the risk of venous thromboembolism (VTE) postoperatively. They further hypothesize that using a target international normalized ratio (INR) of 1.8 is non-inferior to using a target INR of 2.5 in clot prevention.


Condition Intervention Phase
Thromboembolism
 Other: Pharmacogenetic Warfarin Initiation
Other: Clinical Warfarin Initiation (non-pharmacogenetic)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Genetics Informatics Trial (GIFT) of Warfarin to Prevent Deep Venous Thrombosis (DVT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • non-fatal VTE [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]
  • non-fatal major hemorrhage [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]
  • death of any cause [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]
  • INR>=4.0 [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent Time in Therapeutic INR Range [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]
  • Time to first laboratory event (INR > 1.5 + Target INR) [ Time Frame: 4-6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1600
Study Start Date: March 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Target INR 1.8 Other: Pharmacogenetic Warfarin Initiation
We will estimate therapeutic warfarin dose requirements using CYP2C9, VKORC1, and CYP4F2 genotype and clinical information, using algorithms on www.WarfarinDosing.org
Other: Clinical Warfarin Initiation (non-pharmacogenetic)
We will estimate therapeutic dose requirements using clinical information only, using algorithms on www.WarfarinDosing.org
Active Comparator: Target INR 2.5 Other: Pharmacogenetic Warfarin Initiation
We will estimate therapeutic warfarin dose requirements using CYP2C9, VKORC1, and CYP4F2 genotype and clinical information, using algorithms on www.WarfarinDosing.org
Other: Clinical Warfarin Initiation (non-pharmacogenetic)
We will estimate therapeutic warfarin dose requirements using clinical information only, using algorithms on www.WarfarinDosing.org

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 years of age or older
  • must anticipate taking warfarin for at least 4-6 weeks for VTE prophylaxis after hip or knee arthroplasty
  • must be able to give written, informed consent
  • must have venous access
  • must not be institutionalized, incarcerated at the time of enrollment (nursing home okay)
  • must have life expectancy > 6 months
  • must have plans to have regular INR monitoring
  • willing/able to follow-up in 4-6 weeks with a Doppler Ultrasound

Exclusion Criteria:

  • Baseline INR > 1.35
  • knowledge of CYP2C9, VKORC1, or CYP4F2 genotype
  • knowledge of warfarin dose requirements from prior warfarin therapy
  • absolute contraindication or allergy to warfarin therapy (e.g. pregnancy)
  • receiving or planning to receive any anticoagulant besides warfarin (if LMWH or subcutaneous heparin is deemed necessary by the clinician after enrollment, such patients will be allowed to remain in the study)
  • unlikely to be compliant (e.g. due to history of non-compliance, or alcoholism)
  • known thrombophilia, bleeding disorder, or history of serious bleed
  • family or personal history of thromboembolism before age 50
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006733

Contacts
Contact: Elizabeth Do, BA 314-747-9960 edo@dom.wustl.edu

Locations
United States, Missouri
Washington University in St. Louis, School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Elizabeth Do, BA     314-747-9960     edo@dom.wustl.edu    
Principal Investigator: Brian F Gage, MD, MSc            
United States, New York
Hospital for Special Surgery, Weill-Cornell Not yet recruiting
NY, New York, United States, 10021
Contact: Anne Bass, MD            
Principal Investigator: Anne Bass, MD            
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Robert Pendleton, MD            
Principal Investigator: Robert Pendleton, MD            
Principal Investigator: Gwen McMillan, PhD            
Intermountain Medical Center Not yet recruiting
Salt Lake City, Utah, United States, 84157
Contact: Jeffrey L Anderson, MD            
Principal Investigator: Jeffrey L Anderson, MD            
Sponsors and Collaborators
Washington University School of Medicine
Intermountain Health Care, Inc.
University of Utah
Hospital for Special Surgery, New York
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Brian F Gage, MD, MSc Washington University in St. Louis, School of Medicine
  More Information

Additional Information:
pharmacogenetic and clinical warfarin dosing algorithms for trial  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01006733     History of Changes
Other Study ID Numbers: HL097036-01
Study First Received: October 30, 2009
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
pharmacogenetics
arthroplasty
VKORC1
thromboembolism
warfarin

Additional relevant MeSH terms:
Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013