Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease

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)

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DEVICE

Thromboelastography with Platelet Mapping

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

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-29

Primary Completion

2027-04-29

Completion

2027-06-30

FDA Device

Yes

Countries

• United States

Study Locations