Clinical Trial

Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization

Active, Not Recruiting
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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
Protocol Amendment History 3 changes
minor Completion moved earlier: 2026-10 -> 2026-08 2026-07-24
minor Completion pushed: 2026-06 -> 2026-10 2026-07-21
notable Primary completion pushed: 2024-10-30 -> 2026-02-17 2026-05-27
Trial Details
NCT Number NCT07597239
Lead Sponsor Massachusetts General Hospital
Collaborators: Haemonetics Corporation
Conditions Thrombosis, Arterial Occlusive Diseases, Thromboelastography (TEG), Peripheral Arterial Disease(PAD), Stent Thrombosis, Platelet Inhibition, PRU(Platelet Reactivity Unit)
Enrollment 130 participants
Start Date 2020-11-01
Primary Completion 2026-02-17 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-23