Pharmacogenomics of Warfarin in Hispanics and Latinos

NCT02972385 | Recruiting

• 1 other identifier: 1608762767
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Warfarin is a commonly used blood thinner to treat and prevent blood clots. It is important to take the right dose of warfarin because too much can increase the risk of bleeding and too little can increase the risk of blood clots. This is why patients are closely monitored especially when they begin warfarin therapy. When clinicians prescribe warfarin, they have to consider different factors such as patient's age, body size, diet, and other medications that can interact with warfarin. Certain genes have also been found to affect warfarin dose. Individuals have variations in these genes, which can help explain why some patients need higher dose and others require less. These factors have been used to better predict a patient's warfarin dose requirement. However, these predictions were created based on Caucasian populations and they may not be accurate in predicting a safe warfarin dose if a patient is not Caucasian. This study aims to identify new genetic variation that affects warfarin dosing in Hispanic and Latino populations and try to better predict a Hispanic or Latino patient's warfarin dose requirement.

Conditions

Thrombosis; Hemorrhage

Keywords

warfarin; blood clotting

Outcome Measures

Primary Outcomes (1)

• Stable warfarin dose

  Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.

  At time of enrollment

Interventions

Mouthwash sample PROCEDURE

A one time mouthwash sample will be performed.

Blood Draw PROCEDURE

Patients who are receiving a blood draw during their regular clinical appointment will be asked for a blood sample of 15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will also be stored.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be Hispanic and Latino patients on stable doses of warfarin therapy.

You may qualify if:

• At least 18 years of age
• Ability to give informed consent
• Therapeutic INR for at least 2 consecutive clinic visits
• Self-identifies as Hispanic or Latino

You may not qualify if:

• Less than 18 years old
• Unable to give informed consent
• Severe hepatic impairment

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center - Tucson

Tucson, Arizona, 85721, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Retention: Samples with DNA Description: Isolated DNA will be stored in freezers at minus 80 degrees.

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jason H Karnes, PharmD, PhD

CONTACT

520-626-1447; karnes@pharmacy.arizona.edu

Talin A Robinson Catalan, MS

CONTACT

520-278-6114; talinrobinson@arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)