A Genomic Approach to Warfarin Dose Prescription in Admixed Caribbean Hispanics

Completed

Conditions studied: Atrial Fibrillation, Deep Vein Thrombosis, Cardiac Valvular Insufficiency, Coagulopathies, Pulmonary Embolism

In brief

Caribbean Hispanics are a population with a disproportionately high prevalence of cardio-metabolic disorders but with a limited expectation of benefits from current pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription guidelines for this population, who have arisen from European, West African and Amerindian genomic origins to produce a highly heterogeneous population. Our project combines admixture analysis and DNA-sequencing with development of more accurate rules for better predictability of warfarin dosing to immediately serve this medically underserved population.

Key facts

Study ID

NCT02345356

Run by

University of Puerto Rico

People needed

200

Starts

2016-01-01

Expected to finish

2022-05-17

Last updated by the study team

2022-05-19

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Miami VA Healthcare System — Miami, Florida, United States
• UPR University Hospital at Carolina — Carolina, Puerto Rico
• UDH University Hospital at Centro Medico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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