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临床试验/EUCTR2017-003903-23-FR
EUCTR2017-003903-23-FR进行中(未招募)1 期

Assessment of Beta blocker interruption after uncomplicated mYocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization: The ABYSS Study - ABYSS

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 3,700 人开始时间: 2017年10月13日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
3,700

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

  • 1. Male or female > or= 18 years of age
  • 2. Current treatment with BB whatever the drug or the dose used
  • 3. Prior documented acute myocardial infarction 6 months or more before randomisation defined either by:
  • - a documented ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)
  • - a documented episode of Non ST Elevation MI (NSTEMI) with at least one of the followings:
  • i) a documented hypokinetic or akinetic segment on echo or any other imaging technique
  • ii) segmental hypoperfusion Thallium or any other imaging technique
  • iii) segmental aspect of necrosis on MRI
  • 4. Patient affiliated to Social Security
  • 5. Informed consent obtained in writing at enrolment into the study
  • 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 1850
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1850

排除标准

  • 1. Uncontrolled arterial hypertension according to investigator decision
  • 2. Prior episode of heart failure in the past two years of follow-up and/or low left ventricular ejection fraction <40% requiring the use of BB
  • 3. New ACS (in the past 6 months) including UA/NSTEMI and STEMI
  • 4. Persistent angina or ischemia (>10% viable myocardium) requiring the use of BB
  • 5. Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of BB
  • 6. Treatment with other investigational agents or devices (randomisation) within the previous 30 days, or previous enrolment in this trial.

研究者

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