Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Aspirin
  • Clopidogrel
  • Ticagrelor
  • Rivaroxaban
  • Thromboelastography with Platelet Mapping

Treatment groups

484 Participants
are divided into 2 treatment groups

Sponsors and collaborators