Myocardial infarction MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form:
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion 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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; 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: - All-cause death - Stroke - Myocardial infarction (MI) - Hospitalisation for any cardiovascular (CV) reason. ;Timepoint(s) of evaluation of this end point: At the longest follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All individual parameters of MACE o All cause death o Stroke o MI (Classified by type of MI, including Stent Thrombosis) o Hospitalisation for any CV reason: o Angina, Coronary Angiography or Coronary Revascularization (ACS or not): - Urgent coronary revascularisation o Recurrent ischemia (with or without revascularisation) o Heart Failure o Arythmia = Ventricular or Supra-Ventricular Tachycardia o Syncope, Conduction disorders or PaceMaker Implantation o High Blood Pressure Other secondary endpoints: o Cardiovascular (CV) death o Syncope/dizziness requiring a consultation or a hospitalisation. o Invasive procedures (catheterisation, percutaneous coronary intervention (PCI), pace-maker or automatic defibrillator implantation, endoscopy…) o Angina control o Heart Rate Control (Cardiac Frequency during visit) for the first year only o Blood Pressure Control (Blood pressure during visit) for the first year only o An Epidose of Heart Failure (consultation or Hospitalisation) o The quality of life (QoL) will be evaluated in every patient of the ABYSS trial at baseline, 6 and 12 months after randomisation. The composite of : o Any Death and MI o CV death, MI, and stroke. o CV death, MI, and urgent coronary revascularisation. o CV death, MI, and recurrent ischemia requiring hospitalisation (with or without revascularisation). ;Timepoint(s) of evaluation of this end point: M6 and M12 | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed