NCT07613840 Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
| NCT ID | NCT07613840 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Peripheral Arterial Disease (PAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 484 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-04-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 484 participants in total. It began in 2025-04-29 with a primary completion date of 2027-04-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07613840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease (PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07613840 currently recruiting?
Yes, NCT07613840 is actively recruiting participants. Contact the research team at adua1@mgh.harvard.edu for enrollment information.
Where is the NCT07613840 trial being conducted?
This trial is being conducted at Boston, United States, Salem, United States.
Who is sponsoring the NCT07613840 clinical trial?
NCT07613840 is sponsored by Massachusetts General Hospital. The trial plans to enroll 484 participants.