Status:
COMPLETED
Clarification of Optimal Anticoagulation Through Genetics
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Stroke
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 e...
Detailed Description
The objective of the Clarification of Optimal Anticoagulation through Genetics (COAG) trial is to conduct a 1,022 participant, multicenter, double-blind, randomized trial comparing two approaches to g...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT00839657
Start Date
September 1 2009
End Date
November 1 2013
Last Update
April 20 2016
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
University of California San Francisco
San Francisco, California, United States, 04143-0131
3
University of Florida
Gainesville, Florida, United States, 32610-0486
4
Georgia Health Sciences University
Augusta, Georgia, United States, 30912