Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease

NCT07613840 | Recruiting DMC FDA Device

• 1 other identifier: 2024P002975
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs. The main questions it aims to answer are:

• Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure?
• Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment? Researchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better. Participants will:
• Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure
• Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure
• Have medications adjusted based on blood test results if assigned to the TARGET group

Conditions

Peripheral Arterial Disease (PAD); Amputation; Thrombosis; Thrombosis (Stent Thrombosis); Platelet Aggregation Inhibitors; Thromboelastography (TEG); PRU(Platelet Reactivity Unit)

Keywords

Peripheral Artery Disease Thromboprophylaxis; Personalizing Blood Thinners; Clopidogrel Resistance; Thromboelastography with Platelet Mapping (TEG-PM); Graft/ Stent Thrombosis; Platelet Inhibition

Outcome Measures

Primary Outcomes (1)

• Incidence of Arterial Thrombosis in the Treated Limb

  Proportion of participants experiencing graft or stent thrombosis in the revascularized limb, compared between the TARGET and SOC arms. Thrombosis will be assessed via vascular studies including ankle-brachial index, arterial duplex, and toe pressure at scheduled follow-up visits.

  12 months post-revascularization

Secondary Outcomes (4)

• Amputation-Free Survival (AFS)

  12 months post-revascularization

• All-Cause Mortality

  12 months post-revascularization

• Reintervention Rate

  12 months post-revascularization

• Incidence of Bleeding Events

  12 months post-revascularization

Other Outcomes (4)

• Platelet Inhibition Level

  1 week, 1, 3, 6, 9, and 12 months post-revascularization

• Rutherford Score

  1 week, 1, 3, 6, 9, and 12 months post-revascularization

• Clopidogrel Resistance

  Once during follow-up, through study completion, an average of 12 months post-revascularization

Study Arms (2)

TARGET

EXPERIMENTAL

Participants receive postoperative antiplatelet therapy consistent with standard of care, with regimen adjustments guided by serial TEG-PM (Thromboelastography with Platelet Mapping) assessments. The goal is to maintain platelet inhibition within a therapeutic window of 29-86%. If platelet inhibition falls outside this range at any timepoint, the antiplatelet regimen is escalated or de-escalated per a prespecified algorithm. TEG-PM testing occurs at 1 week, 1, 3, 6, 9, and 12 months postoperatively, with repeat testing 7 days after any medication change.

Drug: Aspirin; Drug: Clopidogrel; Drug: Ticagrelor; Drug: Rivaroxaban; Device: Thromboelastography with Platelet Mapping

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants receive standard postoperative antiplatelet therapy per the treating surgeon's preference (dual antiplatelet therapy or aspirin combined with low-dose rivaroxaban) for the 12-month follow-up period. TEG-PM testing is performed at all scheduled timepoints for data collection purposes only; no medication adjustments are made based on results.

Drug: Aspirin; Drug: Clopidogrel; Drug: Ticagrelor; Drug: Rivaroxaban; Device: Thromboelastography with Platelet Mapping

Interventions

Rivaroxaban DRUG

Rivaroxaban is an oral factor Xa inhibitor used in both study arms. In the SOC arm, low-dose rivaroxaban combined with aspirin represents one of two standard postoperative regimens, administered per surgeon preference. In the TARGET arm, rivaroxaban may be initiated or substituted based on TEG-PM platelet inhibition results and clopidogrel resistance testing findings. Full-dose rivaroxaban is reserved for patients who remain persistently hypercoagulable despite stepwise antiplatelet escalation, prior to hematology referral.

Also known as: Xarelto

Standard of Care (SOC); TARGET

Aspirin DRUG

Aspirin is an oral antiplatelet agent that inhibits cyclooxygenase-mediated thromboxane A2 production, reducing platelet aggregation. It serves as the foundational antiplatelet agent in both study arms following lower extremity endovascular revascularization.

Also known as: Acetylsalicylic Acid; ASA

Standard of Care (SOC); TARGET

Clopidogrel DRUG

Clopidogrel is an oral P2Y12 platelet inhibitor used as part of postoperative antiplatelet therapy following lower extremity endovascular revascularization. In the SOC arm, it is administered as part of a fixed dual antiplatelet regimen. In the TARGET arm, it serves as an initial antiplatelet agent, with continuation or substitution determined by TEG-PM platelet inhibition results and VerifyNow P2Y12 resistance testing. If clopidogrel resistance is identified or platelet inhibition remains below the 29% threshold, clopidogrel may be replaced with ticagrelor per the study algorithm.

Also known as: Plavix

Standard of Care (SOC); TARGET

Ticagrelor DRUG

Ticagrelor is an oral, reversible P2Y12 platelet inhibitor. Unlike clopidogrel, ticagrelor demonstrates minimal resistance and more consistent platelet inhibition, making it a preferred escalation agent.

Also known as: Brilinta

Standard of Care (SOC); TARGET

Thromboelastography with Platelet Mapping DEVICE

Whole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function.

Also known as: TEG-PM, TEG 6s, Haemonetics TEG 6s Hemostasis Analyzer

Standard of Care (SOC); TARGET

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 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
• Subject has active stomach ulcers
• Subject has severe hepatic impairment
• Subject has a recent history of intracranial hemorrhage. If the patient has a history of cerebral hemorrhage with no new central nervous system disease of \>1 year, the study team will consult with the

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Salem Hospital (Mass General Brigham)

Salem, Massachusetts, 01970, United States

RECRUITING

Related Publications (9)

• Lee I, Suarez S, Hall R, Majumdar M, Bellomo T, Jessula S, Nuzzolo K, Jefferson DM, Zacharias N, Dua A. Optimizing platelet inhibition in peripheral artery disease: A comparison of mono-antiplatelet therapy and dual-antiplatelet therapy using thromboelastography. Vascular. 2025 Feb;33(1):3-18. doi: 10.1177/17085381241237005. Epub 2024 Mar 5.

  PMID: 38441042 BACKGROUND

• Bates KJ, Moore MM, Cibotti-Sun M. 2024 Lower Extremity Peripheral Artery Disease Guideline-at-a-Glance. J Am Coll Cardiol. 2024 Jun 18;83(24):2605-2609. doi: 10.1016/j.jacc.2024.04.003. Epub 2024 May 14. No abstract available.

  PMID: 38752900 BACKGROUND

• Suarez S, Agrawal A, Patel S, Grobman B, Ghandour S, Morena L, Rodriguez A, Machlus K, Roy T, Eagleton M, Dua A. The Impact of Sex on Antiplatelet and Anticoagulant Thromboprophylaxis in Patients With Peripheral Artery Disease Post-revascularization. Ann Surg. 2024 Sep 1;280(3):463-472. doi: 10.1097/SLA.0000000000006375. Epub 2024 Jun 11.

  PMID: 38860382 BACKGROUND

• Suarez Ferreira S, Agrawal A, Lee I, Rodriguez A, Cieri I, Young E, Patel S, Ghandour S, Morena L, Hagos F, Grobman B, Machlus K, Roy T, Dua A. The Use of Clot Strength as a Predictor of Thrombosis in Peripheral Artery Disease. Ann Vasc Surg. 2024 Dec;109:273-283. doi: 10.1016/j.avsg.2024.06.041. Epub 2024 Jul 26.

  PMID: 39069123 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

• 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

• Hess CN, Norgren L, Ansel GM, Capell WH, Fletcher JP, Fowkes FGR, Gottsater A, Hitos K, Jaff MR, Nordanstig J, Hiatt WR. A Structured Review of Antithrombotic Therapy in Peripheral Artery Disease With a Focus on Revascularization: A TASC (InterSociety Consensus for the Management of Peripheral Artery Disease) Initiative. Circulation. 2017 Jun 20;135(25):2534-2555. doi: 10.1161/CIRCULATIONAHA.117.024469.

  PMID: 28630267 BACKGROUND

• Owens CD, Ho KJ, Conte MS. Lower extremity vein graft failure: a translational approach. Vasc Med. 2008 Feb;13(1):63-74. doi: 10.1177/1358863X07083432.

  PMID: 18372442 BACKGROUND

• Aronow WS. Peripheral arterial disease in the elderly. Clin Interv Aging. 2007;2(4):645-54. doi: 10.2147/cia.s2412.

  PMID: 18225466 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Thrombosis

Interventions

Aspirin; Clopidogrel; Ticagrelor; Rivaroxaban; Thrombelastography

Condition Hierarchy (Ancestors)

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

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; Morpholines; Oxazines; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Anahita Dua, MBCHB, MBA, MSC

CONTACT

262-565-8247; adua1@mgh.harvard.edu

Swechha Bhatt, MBBS

CONTACT

339-242-0052; sbhatt12@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, Harvard Medical School

Model Details: Participants are randomized postoperatively in a 1:1 ratio into one of two groups: the TARGET protocol (interventional arm) or the standard of care (control arm). Randomization uses random block sizes of 2 or 4, stratified by sex and site. Both groups are followed in parallel for 12 months post-revascularization.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 29, 2026
• Study Start: April 29, 2025
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2025-06

Locations

US (2)