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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07597239
Status
Active Not Recruiting

Conditions

  • Arterial Occlusive Diseases
  • PRU(Platelet Reactivity Unit)
  • Peripheral Arterial Disease(PAD)
  • Platelet Inhibition
  • Stent Thrombosis
  • Thromboelastography (TEG)
  • Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin — DRUG
    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 — DRUG
    Clopidogrel 75 mg orally once daily administered as second-line antiplatelet therapy when aspirin monotherapy fails to achieve therapeutic TEG-PM thresholds. Used as part of dual antiplatelet therapy with aspirin.
  • Ticagrelor — DRUG
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    Serial whole blood samples analyzed using thromboelastography with platelet mapping to measure platelet inhibition, aggregation, and coagulation parameters at prespecified timepoints before and after lower extremity revascularization. Results are used to classify participants as high risk or low risk for thrombosis and to guide antiplatelet therapy adjustments.

Study Details

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

Key Dates

Start date
Dec 14, 2022
Status verified
May 2026
Primary completion
Feb 17, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TEG-PM Guided Antiplatelet Therapy
    All participants undergo serial thromboelastography with platelet mapping (TEG-PM) before and after lower extremity revascularization for peripheral artery disease. Based on TEG-PM results, participants are classified as high risk or low risk for thrombosis. High risk participants (platelet inhibition ≤30%, platelet aggregation ≥70%, or ADP maximum amplitude ≥42 mm) undergo stepwise antiplatelet therapy escalation using aspirin, clopidogrel, and/or ticagrelor. Low risk participants whose results fall within the therapeutic range continue their current standard-of-care antiplatelet regimen without modification. All participants undergo one-time clopidogrel resistance testing using the VerifyNow P2Y12 assay.

Primary Outcome Measure

Change in Platelet Inhibition and Aggregation Following Antiplatelet Therapy Adjustment [ Time Frame: Pre-operative baseline through 3 months post-revascularization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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