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Pharmacogenomics of Warfarin in Hispanics and Latinos

This study is currently recruiting participants.
Verified July 2017 by Jason H Karnes, University of Arizona
Sponsor:
ClinicalTrials.gov Identifier:
NCT02972385
First Posted: November 23, 2016
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jason H Karnes, University of Arizona
  Purpose

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.


Condition Intervention
Thrombosis Hemorrhage Procedure: Cheek Swab/ Mouthwash sample Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomics of Warfarin in Hispanics and Latinos

Resource links provided by NLM:


Further study details as provided by Jason H Karnes, University of Arizona:

Primary Outcome Measures:
  • Stable warfarin dose [ Time Frame: At time of enrollment ]
    Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.


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

Estimated Enrollment: 400
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cheek Swab/ Mouthwash sample
    A one time cheek swab or mouthwash sample will be performed.
    Other Name: Buccal Swab
    Procedure: 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.
Detailed Description:

If the patient is willing to hear about the study, during routine clinical care, one of the patient's providers will approach patients meeting the study criteria about participation in the study. Study personnel will not approach potential participants unless permission is given to the patient's provider. If the patient would like to participate in the study, study personnel will discuss details of the study in person during the patient's routine clinical care visit. There will also be a flyers available for posting and for distribution to potential participants.

Participants consenting to the study will be asked to provide a cheek swab or mouthwash sample to provide buccal cells for DNA extraction. If the patient is receiving a blood draw during their regular clinical appointment, participants 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.

Linear regression will be used to test association of SNPs with therapeutic warfarin dose using the algorithms derived by the International Warfarin Pharmacogenomics Consortium. The primary phenotype (weekly stable warfarin dose) will be transformed by square root. SNPs and other variables associated with warfarin dose will be assessed in univariate analyses and entered into stepwise linear regression to determine the adjusted association with dose requirements using R2. Quality control procedures will include deviation from Hardy-Weinberg Equilibrium, and SNP and sample exclusions based on call rates. Ancestry-informative marker (AIM) analysis will be performed to estimate ancestry in each individual.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be Hispanic and Latino patients on stable doses of warfarin therapy.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972385


Contacts
Contact: Jason H Karnes, PharmD, PhD 520-626-1447 karnes@pharmacy.arizona.edu
Contact: Heidi E Steiner, BS 520-626-3326 steiner@pharmacy.arizona.edu

Locations
United States, Arizona
Banner University Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85721
Contact: Jason H Karnes, PharmD, PhD    520-626-1447    karnes@pharmacy.arizona.edu   
Sponsors and Collaborators
University of Arizona
  More Information

Responsible Party: Jason H Karnes, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT02972385     History of Changes
Other Study ID Numbers: 1608762767
First Submitted: November 21, 2016
First Posted: November 23, 2016
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jason H Karnes, University of Arizona:
warfarin
blood clotting

Additional relevant MeSH terms:
Hemorrhage
Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants