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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01006733
Eligibility Criteria:
Inclusion Criteria:
* 65 years of age or older
* must anticipate taking warfarin for at least 4 weeks for VTE prophylaxis after hip or knee arthroplasty
* must be able to give written, informed consent
* must have venous access
* must not be institutionalized, incarcerated at the time of enrollment (nursing home okay)
* must have life expectancy \> 6 months
* must have plans to have regular INR monitoring
* willing/able to follow-up in 3-7 weeks with a Doppler Ultrasound
Exclusion Criteria:
* Baseline INR \> 1.35
* knowledge of CYP2C9, VKORC1, or CYP4F2 genotype
* knowledge of warfarin dose requirements from prior warfarin therapy
* absolute contraindication or allergy to warfarin therapy (e.g. pregnancy)
* receiving or planning to receive any anticoagulant besides warfarin (if low molecular weight heparin (LMWH) or subcutaneous heparin is deemed necessary by the clinician after enrollment, such patients will be allowed to remain in the study)
* unlikely to be compliant (e.g. due to history of non-compliance, or alcoholism)
* known thrombophilia, bleeding disorder, or history of serious bleed in the past 2 years (unless caused by trauma)
* personal history of venous thromboembolism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01006733
Study Brief:
Protocol Section:
NCT01006733