Clarification of Optimal Anticoagulation Through Genetics "COAG"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- 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 Criteria

- 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