2024-512091-35-01招募中3 期
Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial- LEADER PAD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,798
- 试验地点
- 18
- 主要终点
- Rate of major adverse cardiovascular and limb events (MACE or MALE). This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).
研究概览
简要总结
The overall objective of this research program is to examine the efficacy and safety of colchicine 0.5 mg/daily in reducing the incidence of cardiovascular death, myocardial infarction, stroke or severe limb ischemia requiring an intervention including major vascular amputation in PAD patients.
研究设计
- 分配方式
- Randomized
- 主要目的
- Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk
- 盲法
- Double (Analyst, Subject, Investigator, Monitor, Carer)
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
- •Symptomatic atherosclerotic LE PAD fulfilling at least one of the following: a. Intermittent claudication with ankle/arm blood pressure ratio* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. >1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2); b. Rest pain (mostly in foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio* (ABI ≤ 0.90) OR artery stenosis ≥ 50%. * In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable; c. Revascularization defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery; or d. Leg or foot amputation for arterial vascular indications
- •Written informed consent from the patient
排除标准
- •Contraindication to colchicine (including hypersensitivity to the active substance or to any of the excipients)
- •Patients with blood dyscrasias
- •Patients with severe heart failure (NYHA class IV)
- •Patients with severe gastrointestinal insufficiency
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening, or within the 5 half-lives of the study drug, whichever is longer
- •Long term requirement for colchicine for another clinical indication
- •Active diarrhoea
- •eGFR < 30 mL/min/1.73 m2
- •Cirrhosis or severe chronic liver disease
- •Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
- •Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)
- •Patients who are deemed unlikely to return for follow-up
- •Patients with life expectancy < 1 year
结局指标
主要结局
Rate of major adverse cardiovascular and limb events (MACE or MALE). This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).
Rate of major adverse cardiovascular and limb events (MACE or MALE). This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).
次要结局
- Extended MALE; This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention
- Cardiovascular death
- Myocardial infarction
- Stroke
- Hospitalization
- Acute or chronic limb-threatening ischemia
- All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization)
- Total vascular amputation
- Overall mortality
- Any thrombosis or thromboembolism (arterial and venous)
- Fontaine Stage
- Standard Assessment of Global Everyday Activities (SAGEA)
- Vascular Quality of Life Questionnaire-6 (VascQOL-6)
- EuroQol 5 Dimension 5 Level (EQ-5D-5L)
研究者
Dr. Noel Chan, Central Study Investigator
Scientific
Hamilton Health Sciences Corporation
研究点 (18)
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