ThrombosisNCT02972385
Pharmacogenomics of Warfarin in Hispanics and Latinos
An observational study of Thrombosis and Hemorrhage, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Hemorrhage
- What is being tested?
- Mouthwash sample and Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be Hispanic and Latino patients on stable doses of warfarin therapy.
Who may be able to join
- 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
Who cannot join
- Less than 18 years old
- Unable to give informed consent
- Severe hepatic impairment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, 85721
Jason H Karnes, PharmD, PhD, 520-626-1447, karnes@pharmacy.arizona.edu
About this study
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.
Read the 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.
- Conditions
- Thrombosis, Hemorrhage
- Being tested
- Mouthwash sample, Blood Draw
- Keywords
- warfarin, blood clotting
- Medical subject headings
- Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash sampleProcedure or surgery
A one time mouthwash sample will be performed.
Blood DrawProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stable warfarin dose
Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason H Karnes, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972385
- Sponsor's protocol ID
- 1608762767
- Status last verified
- Jun 2024
- First submitted
- 21 Nov 2016
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Warfarin in Hispanics and Latinos
- ClinicalTrials.gov ID
- NCT02972385
- Acronym / sponsor ID
- 1608762767
- Conditions
- Thrombosis, Hemorrhage
- Keywords
- warfarin, blood clotting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be Hispanic and Latino patients on stable doses of warfarin therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 years old
- Unable to give informed consent
- Severe hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouthwash sampleA one time mouthwash sample will be performed. | Procedure or surgery | – |
| Blood DrawPatients 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. | Procedure or surgery | – |
Primary outcome
Stable warfarin dose
Time frame: At time of enrollment
Dose of warfarin required to maintain stable INR for at least 2 consecutive clinic visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Hemorrhage, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason H Karnes, PharmD, PhD (520-626-1447, karnes@pharmacy.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stable warfarin dose (time frame: At time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.