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Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Sponsor: Massachusetts General Hospital
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 more than 60 years and older with peripheral artery disease (PAD) who have undergone infrainguinal endovascular surgery. The main questions it aims to answer are: * Does TEG-PM-guided antiplatelet therapy lower the rate of thrombosis or clinically significant stenosis of the treated artery within 12 months compared with a historical standard-of-care cohort? * How does TEG-PM-guided therapy affect major amputation, amputation-free survival, mortality, and bleeding? Participants will: * Have blood samples taken before the procedure and at 1, 3, and 6 months afterward * Have antiplatelet medications (aspirin, clopidogrel, and/or ticagrelor) escalated or de-escalated based on TEG-PM results through 6 months * Have one additional blood test to check clopidogrel response if taking clopidogrel * Be followed for clinical outcomes through 12 months
Official title: The Use of Thromboelastography With Platelet Mapping to Guide Thromboprophylaxis Following Lower Extremity Revascularization for Peripheral Artery Disease
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2023-01-01
Completion Date
2026-10
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Aspirin
Aspirin 81 mg orally once daily administered as first-line antiplatelet therapy. Used as monotherapy or as part of dual or triple antiplatelet therapy regimen based on TEG-PM results.
Clopidogrel
Clopidogrel 75 mg orally once daily, added to aspirin when ADP-mediated platelet inhibition is \<30% on aspirin monotherapy. Also used in triple therapy with aspirin and ticagrelor if hypercoagulability persists, and reduced or discontinued during de-escalation when platelet inhibition is \>86%.
Ticagrelor
Ticagrelor 90 mg orally twice daily administered when dual antiplatelet therapy with aspirin and clopidogrel fails to achieve therapeutic TEG-PM thresholds. Replaces clopidogrel in dual antiplatelet therapy or added as triple antiplatelet therapy if needed.
Platelet Reactivity Testing
One-time FDA-approved point-of-care platelet reactivity test performed to assess clopidogrel resistance. One citrated blood tube collected and analyzed after participant has been taking clopidogrel for at least 7 days.
Thromboelastography with Platelet Mapping
Whole-blood TEG-PM (TEG 6s, Haemonetics) performed pre-operatively and at 1, 3, and 6 months. ADP-mediated platelet inhibition classifies participants as hypercoagulable (\<30%), therapeutic (30-86%), or hypocoagulable (\>86%) to guide antiplatelet adjustment.
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States