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

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

Conditions

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

Interventions

DRUG

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.

DRUG

Clopidogrel

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.

DRUG

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Thromboelastography with Platelet Mapping

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.

Sponsors & Collaborators

• Haemonetics Corporation

  collaborator INDUSTRY

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Anahita Dua, MBChB, MBA, MSC · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-14

Primary Completion

2024-10-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations