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临床试验/EUCTR2010-022970-14-HU
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

ovartis Pharma Services AG0 个研究点目标入组 10,000 人开始时间: 2011年7月13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)
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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