STEMI or NSTEMI patients being discharged from the index hospitalization with a LVEF>40% without previous heart failure MedDRA version: 20.0 Level: LLT Classification code 10021758 Term: Infarct myocardial System Organ Class: 100000004849
Conditions
Interventions
Trade Name: METOPROLOLO DOC GENERICI - 100 MG COMPRESSE 30 COMPRESSE
Product Name: METOPROLOLO
Product Code: [C07AB02]
Pharmaceutical Form: Tablet
INN or Proposed INN: METOPROLOLO
CAS Number: 37350-
Sponsors
CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) > 18 years old or 18 years old 2) STEMI or STEMI patient 3) LVEF >40% 4) INFORM CONSENT SIGNED 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 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6468
Exclusion criteria
Exclusion criteria: 1) Known allergy or intolerance to beta-blockers 2) Absolute contraindication to beta-blocker therapy according to treating physician judge 3) Prior history of HF, Killip class on admission or during hospitalization = II 4) Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area =1.0 cm2). 5) Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge 6) Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year), 7) Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Incidence rate of the composite of ¿all-cause death, nonfatal reinfarction, or heart failure hospitalization¿.;Secondary Objective: 1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality. ;Primary end point(s): To assess the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI) with a left ventricular ejection fraction >40%. Beta-blocker treatment will be associated with a 20% reduction in the incidence rate of the primary composite endpoint: incidence rate of the composite of “all-cause death, non fatal reinfarction, or heart failure hospitalization”.;Timepoint(s) of evaluation of this end point: Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence rate of individual components of the primary outcome;; Incidence of cardiac mortality.;Timepoint(s) of evaluation of this end point: Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years; Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years | — |
Countries
Italy, Spain
Contacts
Public ContactDIP. RICERCA CARDIOVASCOLARE
IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Outcome results
None listed