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

NCT07597239 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2022P002264
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Thromboelastography; Platelet Mapping; Lower Extremity Revascularization; Thromboprophylaxis; Personalized Antiplatelet Therapy; Clopidogrel Resistance; Platelet Inhibition; Viscoelastic Testing; Platelet Function Testing; Stent Thrombosis; Graft Thrombosis

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Inhibition and Aggregation Following Antiplatelet Therapy Adjustment

  Determine if platelet inhibition and aggregation for participants with coagulation profiles that place them at high risk for thrombosis can be improved to levels not associated with thrombosis following alteration of antiplatelet therapy. High risk is defined as platelet inhibition not greater than 30%, platelet aggregation not less than 70%, or ADP maximum amplitude not less than 42mm on thromboelastography with platelet mapping.

  Pre-operative baseline through 3 months post-revascularization

Secondary Outcomes (1)

• Rate of Graft or Stent Thrombosis

  Up to 12 months post-revascularization

Other Outcomes (4)

• Primary, Primary Assisted, and Secondary Patency Rates

  Up to 12 months post-revascularization

• Amputation Rate

  Up to 12 months post-revascularization

• Bleeding Events

  Up to 12 months post-revascularization

Study Arms (1)

TEG-PM Guided Antiplatelet Therapy

EXPERIMENTAL

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.

Drug: Aspirin; Drug: Clopidogrel; Drug: Ticagrelor; Diagnostic Test: Platelet Reactivity Testing; Diagnostic Test: Thromboelastography with Platelet Mapping

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.

Also known as: Acetylsalicylic Acid

TEG-PM Guided Antiplatelet Therapy

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.

Also known as: Plavix

TEG-PM Guided Antiplatelet Therapy

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.

Also known as: Brilinta

TEG-PM Guided Antiplatelet Therapy

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.

Also known as: VerifyNow P2Y12 Assay

TEG-PM Guided Antiplatelet Therapy

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.

Also known as: TEG-PM

TEG-PM Guided Antiplatelet Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Haemonetics Corporation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• Guo B, Tan Q, Guo D, Shi Z, Zhang C, Guo W. Patients carrying CYP2C19 loss of function alleles have a reduced response to clopidogrel therapy and a greater risk of in-stent restenosis after endovascular treatment of lower extremity peripheral arterial disease. J Vasc Surg. 2014 Oct;60(4):993-1001. doi: 10.1016/j.jvs.2014.03.293. Epub 2014 May 28.

  PMID: 24877854 BACKGROUND

• Majumdar M, Waller D, Poyant J, McElroy I, Lella S, Feldman ZM, Levine E, Kim Y, Nuzzolo K, Kirshkaln A, DeCarlo C, Dua A. Variability of antiplatelet response in patients with peripheral artery disease. J Vasc Surg. 2023 Jan;77(1):208-215.e3. doi: 10.1016/j.jvs.2022.08.015. Epub 2022 Aug 24.

  PMID: 36028157 BACKGROUND

• Guirgis M, Thompson P, Jansen S. Review of aspirin and clopidogrel resistance in peripheral arterial disease. J Vasc Surg. 2017 Nov;66(5):1576-1586. doi: 10.1016/j.jvs.2017.07.065.

  PMID: 28893489 BACKGROUND

• Writing Committee Members; Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jun 18;83(24):2497-2604. doi: 10.1016/j.jacc.2024.02.013. Epub 2024 May 14.

  PMID: 38752899 BACKGROUND

• Majumdar M, Hall RP, Feldman Z, Goudot G, Sumetsky N, Jessula S, Kirshkaln A, Bellomo T, Chang D, Cardenas J, Patell R, Eagleton M, Dua A. Predicting Arterial Thrombotic Events Following Peripheral Revascularization Using Objective Viscoelastic Data. J Am Heart Assoc. 2023 Jan 3;12(1):e027790. doi: 10.1161/JAHA.122.027790. Epub 2022 Dec 24.

  PMID: 36565191 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Arterial Occlusive Diseases; Peripheral Arterial Disease

Interventions

Aspirin; Clopidogrel; Ticagrelor; Thrombelastography

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Anahita Dua, MBChB, MBA, MSC

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, non-randomized, single-site, single-group interventional study. All enrolled participants undergo serial thromboelastography with platelet mapping (TEG-PM) following lower extremity revascularization for peripheral artery disease. Antiplatelet therapy adjustments are made only for participants whose TEG-PM results fall outside prespecified therapeutic thresholds for platelet inhibition and aggregation. Participants whose TEG-PM results fall within the therapeutic range continue their current antiplatelet regimen without modification. Outcomes are compared to a historical observational cohort of patients who underwent lower extremity revascularization under standard of care antiplatelet therapy without TEG-PM guidance.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: December 14, 2022
• Primary Completion: February 17, 2026
• Study Completion: June 1, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)