Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Rev… (NCT07597239) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
United States130 participantsStarted 2022-12-14
Plain-language summary
The goal of this clinical trial is to learn if a blood clotting test called thromboelastography with platelet mapping (TEG-PM) can guide blood-thinning medication decisions in adults 18 years and older with peripheral artery disease (PAD) who have undergone leg artery open or endovascular surgery. The main questions it aims to answer are:
* Can TEG-PM results improve blood-thinning medication levels in participants at high risk for blood clots after surgery?
* Can adjusting blood-thinning medications based on TEG-PM results lower the rate of blood clots forming in their revascularized leg after surgery?
Participants will:
* Have blood samples taken before surgery and at 1 week, 1 month, 2 months, 3 months, 6 months, and up to 9 months after surgery
* Have blood-thinning medications (aspirin, clopidogrel, and/or ticagrelor) adjusted based on TEG-PM results during the first 3 months after surgery
* Have one additional blood test to check if clopidogrel is working properly
* Have their medical records reviewed for 6 months after their last visit to check on their health outcomes
Who can participate
Age range
18 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:
* Patients with a named arterial extremity injury or named vessel revascularization for atherosclerosis requiring open and/or closed revascularization
* Patients at the age of 18 years or older
Exclusion Criteria:
* Patients who are younger than 18 years old
* Known pregnancy (females of childbearing potential will have a pregnancy test prior to surgery as per standard of care)
* Prisoners, defined as those who have been directly admitted from a correctional facility
* No atherosclerosis
* Patient has a contraindication or allergy to antiplatelet medication and/or aspirin
* Patient has contraindications to ticagrelor:
* Active stomach ulcers
* Severe hepatic impairment
* History of intracranial hemorrhage
* Previous allergic response to ticagrelor
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
Change in Platelet Inhibition and Aggregation Following Antiplatelet Therapy Adjustment
Timeframe: Pre-operative baseline through 3 months post-revascularization