Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00839657
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00839657
Study Brief:
Protocol Section:
NCT00839657