Beta Blocker Interruption After Uncomplicated Myocardial Infarction

• Status: Recruiting
• Trial end date: 2023-08-29
• Target enrollment: 0
• Participant gender: All

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 ΒB therapy after an uncomplicated MI after six months or more of follow-up compared to the continuation of βB evaluated by the primary endpoint or death, MI, Stroke and rehospitalization for others cardiovascular reasons.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ACTION Institut de Cardiologie Pitié-Salpêtrière Hospital Paris, France; Groupe Hospitalier Pitie-Salpetriere
• Treatments: Adrenergic beta-Antagonists

Criteria

Inclusion criteria

Subjects meeting all of the following criteria will be considered for enrolment into the study:

1. Male or female +/=18 years of age

2. Current treatment with βB whatever the drug or the dose used

3. Prior acute myocardial infarction 6 months or more before randomisation defined either by:

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• An episode of ST elevation MI with ST segment elevation (STEMI) and/or the presence of Q wave (Type I MI)

• an episode of Non ST Elevation MI (NSTEMI) with preferably 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

• An episode of silent MI discovered on ECG or Cardiac Imaging. Importantly = The mention of an MI on a report is enough to be considered as a prior MI and it is not necessary to retrieve the source document and/or documentation of this prior MI .

4. Patient affiliated to 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:

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 βB;

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 βB;

5. Prior episode of ventricular or supraventricular arrhythmia in the past year of follow-up requiring the use of ΒB;

6. Treatment with other investigational agents or devices within the previous 30 days, or previous enrolment in this trial.

7. Pregnant Women or breast feeding women

8. Patient under legal protection (protection of the court, or in curatorship or guardianship).