EUCTR2010-022970-14-IT进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, eventdriven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10,061
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
- 性别
- All
入选标准
- •- Written informed consent - Male, or Female of non-child-bearing potential - Age = 18 years - Spontaneous MI at least 30 days before randomization. - hsCRP = 2 mg/L
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4746
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2556
排除标准
- •- Pregnant or nursing (lactating) women - Women of child-bearing potential - Any of the following concomitant diseases: 1. Planned coronary revascularization (PCI or CABG) 2. Major non-cardiac surgical or endoscopic procedure within past 6 months 3. Multi-vessel CABG surgery within the past 3 years Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA] 4. Uncontrolled hypertension 5. Uncontrolled diabetes - History or evidence of active tuberculosis (TB) infection Other protocol-defined inclusion/exclusion criteria may apply
研究者
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