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New treatment option for CLTI Defined as Rutherford Category 4 or 5
Official title Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization
ClinicalTrials.gov ID: NCT07512960
What this study is testing
What is Clopidogrel 75 mg/day?
Clopidogrel 75 mg/day is an investigational medicine, being studied as a potential treatment for clti defined as rutherford category 4 or 5.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic limb threatening ischemia (CLTI) is defined as ischemic foot pain at rest or non-healing foot wounds that is attributable to severe peripheral arterial disease (PAD).Revascularization is the cornerstone of therapy to relieve ischemic pain, prevent limb loss and preserve patient autonomy. Revascularization procedures often involve below-the-knee arterial disease in CLTI population.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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)...
- Successful endovascular revascularization involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee...
- Affiliation to a French Health Insurance system
- Patient able to understand and sign a written informed consent form.
You likely can't join if
- 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])
See the full eligibility 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...
- 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...
- 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...
- 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 72 hours after the procedure to enroll and...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.