Clarification of Optimal Anticoagulation Through Genetics

Completed · Phase 3

Conditions studied: Stroke, Venous Thrombosis, Atrial Fibrillation, Atrial Flutter

In brief

Individuals taking warfarin often need frequent dose changes as the international normalized ratio (INR) gets too high or too low which could result in a higher risk of thromboembolism, bleeding and early discontinuation of a highly useful therapy. This study will compare two approaches to warfarin dosing to examine the utility of using genetic information for warfarin dosing.

Key facts

Study ID

NCT00839657

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

1015

Starts

2009-09-01

Expected to finish

2013-11-01

Last updated by the study team

2016-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willingness and ability to sign informed consent
• Able to be followed in outpatient AC clinic
• Expected duration of warfarin therapy of at least 1 month
• AC management for the patient will be performed in-hospital and as an outpatient by clinicians that will adhere to the study dosing algorithms and dose titration plans
• Target INR 2-3

You may not qualify if…

• Currently taking warfarin
• Prior warfarin therapy with known required stable dose
• Clinician opinion that warfarin dosing needs to be adjusted for reasons not accounted for by dosing algorithm
• Abnormal baseline INR (off warfarin) (e.g., due to liver disease, antiphospholipid antibody)
• Contraindication to warfarin treatment for at least 3 months
• Life expectancy of less than 1 year
• Pregnant women or child-bearing women not using medically approved method of birth control (requires negative pregnancy test to exclude pregnancy in child-bearing women)
• Inability to follow-up on a regular basis with anticoagulation practitioners participating in the trial
• Any factors likely to limit adherence to warfarin
• Cognitive or other causes of inability to provide informed consent or follow study procedures
• Participating in another trial that prohibits participation in the COAG trial or planned enrollment in such a trial within the first 6 months of warfarin therapy
• Estimated blood loss of more than 1,000 cc requiring blood transfusions within 48 hours prior to randomization
• Genotype (CYP2C9 or VKORC1) known to participant from prior testing

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Francisco — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Tulane University Health Science Center — New Orleans, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic College of Medicine — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah Health Care — Salt Lake City, Utah, United States
• Marshfield Clinical Research Foundation — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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