Assessment of Beta blocker interruption after uncomplicated mYocardial infarction : The ABYSS Study

Phase 1

• Conditions: Myocardial infarction; MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-003903-23-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 3700

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non-inferiority of the interruption of BB therapy after an uncomplicated MI after one year or more of follow-up compared to the continuation of BB evaluated by the primary endpoint. ;Secondary Objective: To demonstrate the non-inferiority of the interruption of BB therapy after an uncomplicated MI after one year or more of follow-up after compared to the continuation of BB evaluated by the secondary endpoints.;<br> Primary end point(s): The primary endpoint of the study will be evaluated, with one-year minimum follow-up, and will be the composite of Major Adverse Cardiovascular Events (MACE) measured at the longest follow-up including:<br> - All-cause death<br> - Stroke<br> - Myocardial infarction (MI)<br> - Hospitalisation for any cardiovascular (CV) reason.<br> ;Timepoint(s) of evaluation of this end point: At the longest follow-up.