BridgeMD
Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia after Distal Revascularization: a randomized, double-blind trial
EU CTIS ID: 2025-524297-42-00
What this study is testing
To determine whether one year of DAPT (aspirin 75-160 mg + clopidogrel 75 mg / day) compared to 1-month DAPT improve 1-year major amputation-free survival and overall mortality in patients with CLTI undergoing below-theknee endovascular therapy. All patients will also receive as standard of care rivaroxaban 2.5mg x 2.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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) 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 within 7-days involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days
- 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.
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)
- • 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 the patient);
- • Confirmed acute coronary syndrome (ACS) within 30 days prior to randomization
- • Major trauma or accidents within 30 days prior to randomization
- • 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)
See the full eligibility criteria
Who can join
- 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 within 7-days involving below-the-knee arteries (angioplasty/stenting) alone or combining above- and below-the-knee revascularization within the last 7 days
- 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.
What rules you out
- PAD Rutherford category 0, 1, 2, 3 or 6 (Rutherford 6 defined as severe ischemic ulcers or foot gangrene exceeding the digits)
- • 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 the patient);
- • Confirmed acute coronary syndrome (ACS) within 30 days prior to randomization
- • Major trauma or accidents within 30 days prior to randomization
- • 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)
- • 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
- Acute limb ischemia within one month prior to the qualifying revascularization
- Patient deprived of liberty
- Patient under tutorship, curatorship, or legal protection
- Documented pregnancy or lactation
- 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 randomization, 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);
- • Any known hepatic disease associated with coagulopathy or bleeding risk
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.