EUCTR2017-003903-23-FR
Active, not recruiting
Phase 1
Assessment of Beta blocker interruption after uncomplicated mYocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization: The ABYSS Study - ABYSS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myocardial infarction
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 3700
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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