Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07613840
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.
  • Thromboelastography with Platelet Mapping — DEVICE
    Whole-blood, viscoelastic point-of-care assay used to assess real-time coagulation status and platelet function.

Study Details

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

Key Dates

Start date
Apr 29, 2025
Status verified
Jun 2025
Primary completion
Apr 29, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
484 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Anahita Dua, MBCHB, MBA, MSC
[email protected]
+12625658247
Swechha Bhatt, MBBS
[email protected]
339-242-0052
Salem Hospital (Mass General Brigham)SalemMassachusetts01970
Shaidah Deghan, MD, MSC
[email protected]
781-779-9219

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