ISRCTN99954716进行中（未招募）3 期
ow dose colchicine in patients with peripheral artery disease to address residual vascular risk: a randomized trial (LEADER-PAD)
niversity of Bristol0 个研究点目标入组 6,150 人开始时间: 2024年8月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients need to meet the following criteria for inclusion:
- •1. Age > 18 years old
- •2. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
- •2.1. Intermittent claudication with ankle/arm blood pressure ratio* (ABI = 0.90) or artery stenosis = 50% plus one of
- •2.1.1. >1 vascular bed affected by atherosclerosis.
- •2.1.2. Diabetes
- •2.1.3. Heart failure
- •2.1.4. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2)
- •2.2. Rest pain (mostly in the 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
- •2.3. 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.
- •2.4. Leg or foot amputation for arterial vascular indications
- •3. Written or verbal informed consent from the patient
排除标准
- •1. Contraindication to colchicine
- •2. Long-term requirement for colchicine for another clinical indication
- •3. Active diarrhoea
- •4. eGFR < 30 mL/min/1.73 m2 (based on the local method for estimating eGFR)
- •5. Cirrhosis or severe chronic liver disease
- •6. Woman who is pregnant, breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
- •7. Current or planned long-term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin)
- •8. Patients who are deemed unlikely to return for follow-up
- •9. Patients with life expectancy < 1 year
研究者
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