NCT07613840 · Massachusetts General Hospital
Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Incidence of Arterial Thrombosis in the Treated Limb
Time frame: 12 months post-revascularization
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
- Salem, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations