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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02345356
Eligibility Criteria:
Inclusion Criteria:
* Caribbean Hispanic origin (e.g., Puerto Ricans, Dominicans, Cubans), whose parents are Caribbean Hispanics as well
* Age ≥ 21 years and ≤90 years.
* Willingness and ability to sign informed consent.
* Able to be followed up over 3 months.
* Expected duration of warfarin therapy of at least 3 months.
* Anticoagulation management for the patient will be performed in-hospital and/or as an outpatient by clinicians (i.e., participating Physicians, PharmD) that will adhere to the study dosing algorithms and dose-titration plans.
Exclusion Criteria:
* Non-Hispanic patients (race/ethnicity is self-reported by the patients)
* Age \<21 years and \>90 years.
* Currently taking warfarin or any other new oral anticoagulant (e.g., Xarelto, Pradaxa, Eliquis, and Savaysa/Lixiana).
* 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 (i.e., other than age, gender, body size, co-meds, comorbidities, diet, genetics, ancestry, INRs and target INR).
* 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 childbearing women not using medically approved method of birth control.
* Inability to follow-up on a regular basis with anticoagulation practitioners participating in trial.
* Any factors likely to limit adherence to warfarin, (e.g., dementia, alcohol or substance abuse, plans to move in the next 3 months, history of unreliability in medication taking or appointment keeping, significant concerns about participation in the study from spouse, significant other, or family members, lack of support from primary health care provider).
* Sickle cell, HIV-positive/ AIDS patients
* Cognitive or other causes of inability to provide informed consent or follow study procedures.
* Participating in another trial that prohibits participation in the current trial or planned enrollment in such a trial within the first 3 months of warfarin therapy.
* Anemia: a reduction in Hg ≥2g/dl within 48 hours before randomization and requiring blood transfusions.
* Creatinine Clearance (CrCL) ≤ 15 mL/min.
* Genotype (CYP2C9 or VKORC1) known to participant from prior testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT02345356
Study Brief:
Protocol Section:
NCT02345356