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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Bristol-Myers Squibb |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00839657 |
Individuals taking warfarin often need frequent dose changes as the 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.
Condition | Intervention | Phase |
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Stroke Venous Thrombosis Atrial Fibrillation Atrial Flutter |
Behavioral: Genotype-guided dosing algorithm for warfarin Behavioral: Clinical-guided dosing algorithm for warfarin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Multi-Center, Double-Blind Clinical Trial to Evaluate the Use of Clinical Plus Genetic Information to Guide Warfarin Therapy Initiation and Improve Anticoagulation Control for Patients |
Estimated Enrollment: | 1238 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive warfarin genotype-guided dosing, which involves warfarin dosing using clinical and genotype data.
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Behavioral: Genotype-guided dosing algorithm for warfarin
Initial dosing of warfarin for the first 3-4 days of treatment will be determined by an algorithm that uses clinical and genetic information. Following this initiation dose of warfarin, a second dose adjustment will be made after 3 and/or 4 doses of warfarin using a dose revision algorithm that incorporates the clinical and genetic information. |
2: Active Comparator
Participants will receive warfarin clinical-guided dosing, which involves warfarin dosing using clinical data.
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Behavioral: Clinical-guided dosing algorithm for warfarin
Initial dosing of warfarin for the first 3-4 days of treatment will be determined by an algorithm that uses clinical information. Following this initiation dose of warfarin, a second dose adjustment will be made after 3 and/or 4 doses of warfarin using a dose revision algorithm that incorporates the clinical information.
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The objective of the Clarification of Optimal Anticoagulation through Genetics (COAG) trial is to conduct a 1,238 participant, multicenter, double-blind, randomized trial comparing two approaches to guiding warfarin therapy initiation: 1) initiation of warfarin therapy based on algorithms using clinical information and an individual's genotype using genes known to influence warfarin response ("genotype-guided dosing"), and 2) initiation of warfarin therapy based on algorithms using only clinical information ("clinical-guided dosing"). The study hypothesis is that the use of genetic and clinical information for selecting the dose of warfarin during the initial dosing period will lead to improvement in stability of AC relative to a strategy that incorporates only clinical information (without genetics) for initial dosing. Each study arm will include a baseline dose initiation algorithm and a dose revision algorithm applied over the first 4 to 5 doses of warfarin therapy. By comparing the two strategies in this trial, the study will be able to determine if genetic information provides added benefit above and beyond what can be gleaned simply with clinical information. This study is a proof-of-concept efficacy trial. Efficacy is defined as a measure of whether, under optimal application, dosing algorithms will lead to improvement in care. The trial will thus answer the question: "can the use of clinical plus genetic information lead to an improvement in anticoagulation control above and beyond the use of only clinical information during the initiation of warfarin, when applied in a uniform and optimal manner to all patients?" Because efficacy has not yet been established for genotype-guided dosing of warfarin, it is important to first test whether this approach can, indeed, improve anticoagulation outcomes under controlled conditions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yves D Rosenberg, MD, MPH | 301-435-1292 | rosenbey@nhlbi.nih.gov |
Contact: Eleanor B Schron, MS, RN, PhD | 301-435-0550 | schrone@nhlbi.nih.gov |
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 04143-0131 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610-0486 | |
United States, Maryland | |
University of Maryland School of Medicine | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, Minnesota | |
Mayo Clinic College of Medicine | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555 | |
United States, Utah | |
Intermountain Medical Center | |
Murray, Utah, United States, 84157-7000 | |
United States, Wisconsin | |
Marshfield Clinical Research Foundation | |
Marshfield, Wisconsin, United States, 54449 |
Principal Investigator: | Stephen E Kimmel, MD, MSCE | University of Pennsylvania |
Responsible Party: | University of Pennsylvania School of Medicine ( Stephen E. Kimmel, MD, MSCE ) |
Study ID Numbers: | 623, N01 HV88210, HHSN268200800003C |
Study First Received: | February 6, 2009 |
Last Updated: | February 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00839657 History of Changes |
Health Authority: | United States: Federal Government |
Embolism Thrombosis |
Heart Diseases Anticoagulants Cerebral Infarction Stroke Vascular Diseases Warfarin Thrombosis |
Atrial Flutter Embolism and Thrombosis Embolism Venous Thrombosis Atrial Fibrillation Arrhythmias, Cardiac |
Heart Diseases Anticoagulants Hematologic Agents Vascular Diseases Warfarin Pharmacologic Actions Atrial Flutter Thrombosis |
Embolism and Thrombosis Pathologic Processes Therapeutic Uses Venous Thrombosis Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |