Recruiting

TARGET Plan

Sponsor:

Massachusetts General Hospital

Code:

NCT07613840

Conditions

Peripheral Arterial Disease (PAD)

Amputation

Thrombosis

Thrombosis (Stent Thrombosis)

Platelet Aggregation Inhibitors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aspirin

Clopidogrel

Ticagrelor

Rivaroxaban

Thromboelastography with Platelet Mapping

Study Details

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

Study ID

NCT07613840

Start date

Apr 29, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

484 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TARGET

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.

active comparator: Standard of Care (SOC)

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.

Interventions

Aspirin

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.

Clopidogrel

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.

Ticagrelor

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.

Rivaroxaban

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.

Thromboelastography with Platelet Mapping

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

Primary outcome measure

  • Incidence of Arterial Thrombosis in the Treated Limb [ Time Frame: 12 months post-revascularization ]

Central Contacts and Locations

Central contacts

Anahita Dua, MBCHB, MBA, MSC

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

Swechha Bhatt, MBBS

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Anahita Dua, MBCHB, MBA, MSC

+12625658247adua1@mgh.harvard.edu

Swechha Bhatt, MBBS

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

Salem Hospital (Mass General Brigham)

Recruiting

Salem, Massachusetts, United States, 01970

Contacts

Shaidah Deghan, MD, MSC

781-779-9219sdeghan@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 29, 2026

Last verified

Jun, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-29.