Peripheral Artery Disease Clinical Trials

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Personalizing Post Surgical Thromboprophylaxis for Patients With Peripheral Artery Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Salem Hospital (Mass General Brigham)
RECRUITING
Salem
Contact Information
Primary
Anahita Dua, MBCHB, MBA, MSC
adua1@mgh.harvard.edu
262-565-8247
Backup
Swechha Bhatt, MBBS
sbhatt12@mgh.harvard.edu
339-242-0052
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 484
Treatments
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.
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov