Recruiting

Warfarin

Sponsor:

University of Arizona

Code:

NCT02972385

Conditions

Thrombosis

Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mouthwash sample

Blood Draw

Study Details

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

Study ID

NCT02972385

Start date

Sep, 2016

Status verified date

Jun, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

Mouthwash sample

A one time mouthwash sample will be performed.

Blood Draw

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.

Primary outcome measure

  • Stable warfarin dose [ Time Frame: At time of enrollment ]

Central Contacts and Locations

Central contacts

Jason H Karnes, PharmD, PhD

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

Talin A Robinson Catalan, MS

520-278-6114talinrobinson@arizona.edu

Locations

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Jason H Karnes, PharmD, PhD

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

More Information

Sponsor

University of Arizona

Last update posted

Jun 27, 2024

Last verified

Jun, 2024

Keywords

  • warfarin
  • blood clotting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2024-06-27.