EUCTR2005-000960-25-GB进行中（未招募）1 期
Role of Inflammation and Platelet Activation in the adverse Cardiovascular Outcomes of Patients with Critical Limb Ischaemia - a double-blind randomised trial of Clopidogrel. - Platelet activation and Clopidogrel in Critical Limb Ischaemia
othian NHS trust0 个研究点目标入组 200 人开始时间: 2005年4月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients aged 40-80 years scheduled for infra-inguinal lower limb revascularisation or amputation for critical limb ischaemia will be recruited into the trial. Critical limb ischemia will be defined as breakdown of the skin (ulcer or gangrene) and/or pain in the foot even at rest as a result of arterial disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non-atherosclerotic vascular disease
- •Sudden acute limb ischaemia requiring emergency surgery within a few hours
- •Patients scheduled for supra-inguinal or aortic surgery
- •Acute coronary syndrome within 3 months before surgery
- •Current active bleeding (e.g. peptic ulcer disease)
- •Previous or current intracranial haemorrhage
- •Plan for epidural or spinal anaesthesia
- •Bleeding diathesis
- •Uncontrolled hypertension
- •Thrombocytopenia
- •Hypersensitivity or allergy to thienopyridines
- •Current warfarin or thienopyridine use
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