2025-524297-42-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 614
- 试验地点
- 24
- 主要终点
- Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 m
- •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
研究组 & 干预措施
LACTOSE MONOHYDRATE
Placebo
干预措施: LACTOSE MONOHYDRATE (Drug)
Clopidogrel Viatris 75 mg film-coated tablets
Test
干预措施: Clopidogrel Viatris 75 mg film-coated tablets (Drug)
结局指标
主要结局
Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.
Amputation-free survival at 12 months, defined as time from randomization until major amputation (defined as above-the-ankle amputation) or death from any cause, whichever occurs first, for all subjects.
次要结局
- Individual component of the combined primary endpoint: major amputation, overall mortality at 12 months.
- Costs at 12 months
- Bleeding leading to transfusion of two or more units of whole blood or red cells
- MALE, a combined secondary endpoint at 12 months, defined by the occurrence of either one of the following items whichever occurs first: re-intervention on the index arterial segment (Target Lesion Revascularization/TLR), acute limb ischemia, major amputation of the index limb (above-the-ankle amputation)
- MACE, a combined secondary endpoint at 12 months, defined by the occurrence of either of the following items whichever occurs first: myocardial infarction, stroke or cardiovascular death
- Change between inclusion and 12 months in quality of life using a disease-specific QoL Questionnaire commonly used in CLTI patients (VascuQoL-6 questionnaire) and a generic one, the EQ-5D-5L questionnaire
- Fatal bleeding and/or symptomatic bleeding in a critical area/organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome)
- Bleeding causing a fall in hemoglobin level of 2 g/dL or more
- Requiring intervention (medical practitioner-guided medical or surgical treatment to stop or treat bleeding, including temporarily or permanently discontinuing or changing the dose of a medication or study drug),
- Resulting in hospitalization or inducing an increase in the duration of hospitalization,
- Prompting evaluation (leading to an unscheduled visit to a healthcare professional and diagnostic testing, either laboratory or imaging)
- Net clinical benefit outcome (composite outcome comprising deaths, MALE, MACE and major bleeding events)
- Quality of life: VascuQol-6 and EQ-5D-5L scales
- Incremental cost-effectiveness and utility ratio (ICUR)
研究者
Pr. Joseph EMMERICH
Scientific
Fondation Hopital Saint Joseph
研究点 (24)
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