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Clinical Trials/EUCTR2017-003903-23-FR
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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites3,700 target enrollmentOctober 13, 2017

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.

Registry
who.int
Start Date
October 13, 2017
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

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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