Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT (NCT01006733) | Clinical Trial Compass
CompletedPhase 3
Genetics Informatics Trial (GIFT) of Warfarin to Prevent DVT
United States1,598 participantsStarted 2011-03
Plain-language summary
Blood clots contribute to the death of at least 100,000 Americans each year. Because many of these deaths occur suddenly where treatment is impossible, the best treatment is prevention. With this grant, researchers in Missouri, New York, Utah, Illinois, and Texas are developing strategies to improve the safety and effectiveness of clot prevention by customizing a popular blood thinner (warfarin) to each person's genetic and clinical profile. They hypothesize that the use of genetics to guide warfarin therapy will reduce the risk of venous thromboembolism (VTE) postoperatively. They further hypothesize that using a target international normalized ratio (INR) of 1.8 is non-inferior to using a target INR of 2.5 in VTE prevention.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 65 years of age or older
* must anticipate taking warfarin for at least 4 weeks for VTE prophylaxis after hip or knee arthroplasty
* must be able to give written, informed consent
* must have venous access
* must not be institutionalized, incarcerated at the time of enrollment (nursing home okay)
* must have life expectancy \> 6 months
* must have plans to have regular INR monitoring
* willing/able to follow-up in 3-7 weeks with a Doppler Ultrasound
Exclusion Criteria:
* Baseline INR \> 1.35
* knowledge of CYP2C9, VKORC1, or CYP4F2 genotype
* knowledge of warfarin dose requirements from prior warfarin therapy
* absolute contraindication or allergy to warfarin therapy (e.g. pregnancy)
* receiving or planning to receive any anticoagulant besides warfarin (if low molecular weight heparin (LMWH) or subcutaneous heparin is deemed necessary by the clinician after enrollment, such patients will be allowed to remain in the study)
* unlikely to be compliant (e.g. due to history of non-compliance, or alcoholism)
* known thrombophilia, bleeding disorder, or history of serious bleed in the past 2 years (unless caused by trauma)
* personal history of venous thromboembolism
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
For Aim 1: The composite outcome of: non-fatal venous thromboembolism (VTE), non-fatal major hemorrhage, INR>=4.0, and death.
Timeframe: 30-days, except that VTE may be detected up to day 60
2
For Aim 2: The composite outcome of: non-fatal venous thromboembolism (VTE) and death.