EUCTR2010-022970-14-HU进行中(未招募)1 期
A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP - CANTOS
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
- 10,000
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
- •- 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3000
排除标准
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential
- •Any of the following concomitant diseases
- •Planned coronary revascularization (PCI or CABG)
- •- Major non-cardiac surgical or endoscopic procedure within past 6 months
- •- Multi-vessel CABG surgery within the past 3 years
- •- Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].
- •- Uncontrolled hypertension
- •- 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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