Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
Recruiting now · Not applicable
Conditions studied: Peripheral Arterial Disease (PAD), Amputation, Thrombosis, Thrombosis (Stent Thrombosis), Platelet Aggregation Inhibitors, Thromboelastography (TEG), PRU(Platelet Reactivity Unit)
In brief
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 facts
- Study ID
- NCT07613840
- Run by
- Massachusetts General Hospital
- People needed
- 484
- Starts
- 2025-04-29
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Salem Hospital (Mass General Brigham) — Salem, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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