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临床试验/EUCTR2004-001959-11-SK
EUCTR2004-001959-11-SK进行中(未招募)1 期

Effects of ivabradine on cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction. A three-year randomised double-blind placebo-controlled international multicentre study. - BEAUTIF

Institut de Recherches Internationales Servier0 个研究点目标入组 9,650 人开始时间: 2005年2月16日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
9,650

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

  • The main inclusion criteria will be:
  • (1) history of coronary artery disease documented on a coronary angiography or by a previous myocardial infarction or a coronary revascularisation and
  • (2) left ventricular systolic dysfunction defined as a left ventricular ejection fraction equal to 39% or lower on a two-dimensional echocardiography and a left ventricular dilatation defined as an echocardiographically measured short-axis internal dimension greater than 56 millimetres and
  • (3) sinus rhythm and resting heart rate equal to or higher than 60 beats per minute and
  • (4) informed consent obtained.
  • 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

  • The main exclusion criteria will be:
  • (1) unstable cardiovascular condition
  • (2) severe congestive heart failure (class IV of the classification of the New-York Heart Association)
  • (3) contra-indications to the administration of ivabradine.

研究者

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