Beta Blocker Interruption After Uncomplicated Myocardial Infarction

  • STATUS
    Recruiting
  • End date
    Aug 29, 2023
  • participants needed
    3700
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 26 January 2021
stroke
myocardial infarction
infarct
beta blockers
q waves
acute myocardial infarction

Summary

ABYSS is a national, multicenter, randomised, open label trial using the PROBE study design, that will evaluate the non-inferiority of the interruption of B therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of B evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons.

Description

Despite the outstanding progress made in cardiac care over the last few years, cardiovascular diseases remain the leading cause of morbidity and mortality in developed countries.

After the initial clinical event, patients are considered to have a chronic disease which combined with the increasing actual life expectancy patients with CAD are a major source of expenses due to their life-long treatment and follow-up.

B are prescribed during the initial hospitalisation for MI and in the post-MI phase. European (European Society of Cardiology, ESC) and American (ACC/AHA) guidelines initially gave B therapy a class I recommendation for MI or acute coronary syndrome (ACS) for the first year of treatment and extended such recommendation without solid data up to 3 years after MI , . However, there has been no recent clinical trial to evaluate safety and efficacy of long term B therapy in the contemporary therapeutic era. Taking such lack of evidence in account and acknowledging that clinical practice has changed, the latest ESC STEMI (2014) and NSTEMI (2015) Guidelines degraded the recommendation for the use of B in post MI patients (Class IIa B) during the hospitalization period and they question the validity of its use after the initial stabilization phase. This was confirmed in the 2017 STEMI Guidelines.

The primary objective of the ABYSS trial is to demonstrate the non-inferiority of the interruption of B therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of B evaluated by the primary endpoint.

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:

  • All-cause death
  • Stroke
  • Myocardial infarction Hospitalisation for other cardiovascular (CV) reason.

It is expected that the interruption of B therapy will not alter the prognosis of patients and improve safety and quality of life of patients and considerably reduce healthcare direct or indirect costs.

Details
Condition Myocardial Infarction, Ischemic Heart Disease, Heart Attack (Myocardial Infarction), Cardiac Ischemia, Myocardial Ischemia, heart attack, myocardial infarction (mi), cardiac infarction, heart attacks, myocardial necrosis
Treatment Beta-blockers withdrawal, Continuation of the Betablockers (βB) treatment
Clinical Study IdentifierNCT03498066
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Myocardial Ischemia or Ischemic Heart Disease or Cardiac Ischemia or Myocardial Infarction or Heart Attack (Myocardial Infarction)?
Do you have any of these conditions: heart attack or myocardial infarction (mi) or Cardiac Ischemia or cardiac infarction or Ischemic Heart Disease or Myocardial Infarction or Heart Attac...?
Do you have any of these conditions: Ischemic Heart Disease or Myocardial Ischemia or cardiac infarction or Myocardial Infarction or Cardiac Ischemia or heart attack or myocardial necrosi...?
Do you have any of these conditions: heart attack or Myocardial Infarction or Ischemic Heart Disease or myocardial necrosis or Myocardial Ischemia or Heart Attack (Myocardial Infarction) ...?
Subjects meeting all of the following criteria will be considered for enrolment into the study
Male or female 18 years of age
Current treatment with B whatever the drug or the dose used
Prior documented acute myocardial infarction 6 months or more before randomisation defined either by
a documented ST elevation MI with ST segment elevation and/or the presence of Q wave (Type I MI)
a documented episode of Non ST Elevation MI with at least one of the followings
a documented hypokinetic or akinetic segment on echo or any other imaging technique
segmental hypoperfusion Thallium or any other imaging technique
segmental aspect of necrosis on MRI 4. Patient affiliated to French Social Security 5. Informed consent obtained in writing at enrolment into the study

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study
Uncontrolled arterial hypertension according to investigator decision
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 B
New ACS (in the past 6 months) including UA/NSTEMI and STEMI
Persistent angina or ischemia (>10% viable myocardium) requiring the use of B
Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of B
Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial
Pregnant Women or breast feeding women
Patient under legal protection (protection of the court, or in curatorship or guardianship)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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