Using pharmacogenomic information to improve warfarin dosing in African American patients
Implementation of Point-of-Care Pharmacogenomic Decision Support Accounting for Minority Disparities
This study is testing if using genetic information can help doctors give the right dose of warfarin to African American patients in the hospital to improve their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03225820 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of delivering pharmacogenomic results at the point-of-care in inpatient settings, focusing on African American patients who may face health disparities. It aims to determine if providing pharmacogenomic-based dosing guidance for warfarin can enhance clinical outcomes. Patients will be consented and genotyped for actionable variants predicting drug response or toxicity risk during their hospital stay. The study will involve multiple institutions, including The University of Chicago, University of Illinois at Chicago, and Northwestern University.
Who should consider this trial
Good fit: Ideal candidates for this study are African American adults aged 18 and older who are likely to initiate warfarin therapy.
Not a fit: Patients with liver or kidney transplantation considerations, active leukemia, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved warfarin dosing and better health outcomes for African American patients.
How similar studies have performed: Other studies have shown promise in using pharmacogenomic information to improve medication management, but this specific approach focusing on minority disparities is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be at least 18 years of age. * Patients must self-identify as African American Exclusion Criteria: * Patients who have undergone, or are being actively considered for, liver or kidney transplantation. * Patients with known active or prior leukemia. * Inability to understand and give informed consent to participate. * For patients being recruited to the warfarin sub-study, those with a glomerular filtration rate or creatinine clearance \<30 mL/min34.
Where this trial is running
Chicago, Illinois and 1 other locations
- The University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Peter O'Donnell, MD — University of Chicago
- Study coordinator: Cancer Clinical Trials Office
- Email: cancerclinicaltrials@bsd.uchicago.edu
- Phone: 1-855-702-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.