How long to take two blood-thinning medicines after leg artery procedures in CLTI
Official title: Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization: a Randomized, Double-blind Trial PALADIN [PeripherAL Arterial DIsease Network] -DAPTCLTI
Run by Fondation Hôpital Saint-Joseph · NCT07512960 · Data updated 2026-11-12
This study tests whether a shorter course of dual antiplatelet therapy after below-the-knee artery revascularization helps people with chronic limb threatening ischemia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 614 (estimated) |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | June 12, 2026 |
| Main results expected | May 30, 2030 |
| Study ends | November 30, 2030 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07512960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with CLTI (Rutherford 4 or 5) who recently had successful below-the-knee endovascular revascularization and meet consent and medical criteria.
✕Probably not a fit
Patients who do not experience a benefit may have higher bleeding risk without reduced clotting events, or may not respond to clopidogrel.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares two durations of dual antiplatelet therapy (aspirin plus clopidogrel) after endovascular treatment of below-the-knee arteries in patients with CLTI. Participants are adults with Rutherford category 4 or 5 CLTI who recently had successful below-the-knee revascularization and are randomized to different DAPT durations. The trial uses a clopidogrel 75 mg/day arm versus placebo in a blinded design to determine the optimal length of therapy. Outcomes of interest include limb outcomes, mortality, and major adverse cardiovascular events. The study addresses a gap in guidelines regarding antithrombotic strategies after below-the-knee PAD interventions.
Why it matters
Potential benefit: If successful, the trial could define an optimal DAPT duration that balances clot prevention with bleeding risk for patients after below-the-knee revascularization.
How similar studies have gone: There is limited prior evidence specifically on DAPT duration after below-the-knee revascularization in CLTI; this trial explores a relatively novel question.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Saint Joseph
Paris, Île-de-France Region, France Recruiting
Study contacts
- Principal investigator: Joseph Emmerich, Pr — Hôpital Paris Saint Joseph
- Study coordinator: Joseph Emmerich, Pr
- Email: jemmerich@ghpsj.fr
- Phone: +33 1 44 12 37 64
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.