A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve (NCT01633957) | Clinical Trial Compass
UnknownNot Applicable
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
China200 participantsStarted 2012-06
Plain-language summary
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. However, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement.
Interindividual variation in warfarin dose is mediated by multiple factors.Advanced models using combinations of clinical attributes and genetic factors(CYP2C9, VKORC1, and CYP4F2) explain 50-75% of variability in warfarin dose requirements.These warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. The investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.
Who can participate
Age range
18 Years – 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:
* the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement
* willing to join in the clinical trial and comply with the protocol.
Exclusion Criteria:
* other ethnic groups than Han
* previously receive any other cardiac surgery
* emergent surgery
* simultaneously carry out other cardiac surgeries,such as CABG
* age younger than 18y or older than 65 year
* drug abuser and wine abuser
* any malignancy
* moderate or severe hepatic or kidney insufficiency
* any thyroid disease
* the history of warfarin or VitK consumption 2 week before the surgery
* any hematological disease or history of bleeding
* combination with any drugs that significantly influence warfarin other than Cordarone
* pregnancy
* any contraindication of warfarin
* infectious endocarditis
* advanced valvular disease
* pathological obesity
* psychological disease
* any patient having joined in other clinical trial in the previous 30d
* basic INR \> 1.4
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
time to steady dosage
Timeframe: from seven days after the operation to thirty days after the operation
2
Time in Therapeutic Range
Timeframe: from five days after the operation to thirty days after the operation