Blood thinner duration trial aims to save limbs in severe artery disease
NCT ID NCT07512960
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking two blood thinners (aspirin and clopidogrel) for 12 months after leg artery surgery is better than taking them for just 1 month in people with severe leg artery disease. The goal is to see if longer treatment prevents amputations or death. About 614 participants will be randomly assigned to either continue clopidogrel or switch to a placebo after the first month.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clopidogrel
- What this could lead to
- If successful, this could establish the optimal duration of dual anti-platelet therapy to prevent amputations and deaths in people with severe leg artery disease.
- What could go wrong
- This is a phase 3 trial, but the optimal therapy duration is still debated. Results may not apply to all patients, and there is a risk of bleeding with longer anti-platelet use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 614 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years * Hospitalized patients with CLTI defined as Rutherford category 4 (ischemic rest pain) or 5 (minor tissue loss, non-healing ulcer, focal gangrene) evolving for \> 2 weeks + one or more abnormal hemodynamic parameters: ankle-brachial index (ABI) \<0.4 (using higher of the dorsalis pedis and posterior tibial arteries), absolute highest ankle pressure \<50 mm Hg, absolute toe pressure \<30 mm Hg. * Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days prior to randomization * Affiliation to a French Health Insurance system * Patient able to understand and sign a written informed consent form. * In women of childbearing potential: negative serum pregnancy test and use of adequate contraception. (According to CTFG guidelines, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.) Exclusion Criteria: * PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe * ischemic ulcers or foot gangrene exceeding the digits) * Acute limb ischemia within one month prior to the qualifying revascularization * Platelet count \< 100x109/L * Need for dual antiplatelet therapy for other reason than PAD * Need for concomitant treatment with anticoagulant (VKA or DOAC \[except low dose rivaroxaban 2.5 mg x 2\]) * Known allergy or hypersensitivity to aspirin/clopidogrel * Exclusion criteria related to bleeding risks or systemic conditions: * Medical history or active clinically significant bleeding, lesions, or conditions within the last 6 months prior to inclusion, considered to be a significant risk for major bleeding (this may include current medically confirmed gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, current or recent brain or spinal injury, known esophageal varices, or major intraspinal or intracerebral vascular abnormalities; * Severe hepatic impairment or any known hepatic disease associated with coagulopathy or bleeding risk; * Any condition requiring dialysis or renal replacement therapy or a renal impairment at screening assessed with an estimated glomerular filtration rate \<15 mL/min/1.73 m2 (if a patient's eGFR is \<30 mL/min/1.73 m2 prior to the procedure, it must remain \>15 mL/min/1.73 m2 72 hours after the procedure to enroll and randomize the patient); * Confirmed acute coronary syndrome (ACS) within 30 days prior to inclusion; Major trauma or accidents within 30 days prior to inclusion; * Any medically documented history of intracranial hemorrhage, stroke, or transient ischemic attack (TIA); * Known active malignancy (as determined through review of medical history), excluding local skin cancer (basal or squamous cell carcinoma); * Poorly controlled diabetes (at the discretion of the investigator); * Severe uncontrolled hypertension (at the discretion of investigator); * Other exclusion criteria : * Previous (within 30 days) or concomitant participation in another clinical interventional study (drug or device) * Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person (e.g., employee or student of the investigational site) * Expected impossible follow-up or poor compliance * Patient deprived of liberty * Patient under tutorship, curatorship, or legal protection * Documented pregnancy or lactation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Saint Joseph
RECRUITINGParis, Île-de-France Region, 75014, France
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