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
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
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
Parallel
Aspirin
DrugAspirin 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
DrugClopidogrel 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
DrugTicagrelor 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
DrugRivaroxaban 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
DeviceWhole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function.
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.
Amputation-Free Survival (AFS)
All-Cause Mortality
Reintervention Rate
Incidence of Bleeding Events
Platelet Inhibition Level
Serial TEG-PM derived platelet inhibition percentages tracked over time to assess maintenance within the therapeutic window of 29-86% in the TARGET arm.
Rutherford Score
The Rutherford Classification System is a standardized seven-category scale (Grade 0-6) used to classify the severity of peripheral artery disease based on clinical symptoms and hemodynamic measurements. Category 0 indicates no symptoms with normal hemodynamic findings; Category 1 indicates mild claudication; Category 2 indicates moderate claudication; Category 3 indicates severe claudication; Category 4 indicates ischemic rest pain; Category 5 indicates minor tissue loss; and Category 6 indicates major tissue loss or gangrene. Higher scores indicate worse limb ischemia and poorer functional status. The score is assessed by the treating physician at each scheduled follow-up visit.
Clopidogrel Resistance
Assessed via VerifyNow P2Y12 assay in all patients who receive clopidogrel for at least 7 days during the study period.
Wound Status
Wound status at the revascularization site is assessed at each scheduled follow-up visit by clinical examination. Clinicians document the presence or absence of a wound and, if present, categorize its status as one of four categories: stable, better, worse, or new wound. Changes in wound status between visits are tracked over time and recorded in conjunction with overall limb status assessment including thrombosis, amputation, and reintervention events.
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