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
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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