Systolic left ventricular dysfunction after AMI MedDRA version: 7.0 Level: LLT Classification code 10049694
Conditions
Interventions
Trade Name: BIFRIL
Product Name: zofenopril
Pharmaceutical Form: Coated tablet
INN or Proposed INN: zofenopril
CAS Number: 81938-43-4
Sponsors
Menarini International Operation Luxembourg -SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At day 1: a) Written informed consent of the patient; b) Male and female aged 18-85 years; c) Patient suffering from acute myocardial infarction during the 24 hours before inclusion in the study and treated or not with thrombolytic drugs in the previous 12 hours. At day 5: Acute myocardial infarction with clinical (Killip class > 1, NYHA class > I, combination of 3"1 heart sound + pulmonary rales + pulmonary congestion on chest X-ray) or echocardiographic (LVEF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At day 1: a) Ipersensibility to ACEI or ASA; b) Systemic hypotension (SBP 2.5 mg/dL (221 µmol/L); d) Angioneurotic oedema; e) Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with one kidney; g) Mitral or aortic stenosis; h) Thrombocytopenia, leucopenia, agranulocytosis; i) Hemorrhagic diseases, disease that may give bleeding (i.e gastric ulcer); j) Acute stroke; k) LES and/or systemic sclerodermia; l) Concomitant chronic anticoagulant treatment; m) Patients undergoing primary PTCA with combined antiplatelet therapy including Clopidogrel + ASA; n) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; o) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception. At day 5: a) Ipersensibility to ACEI, or ASA; b) Systemic hypotension (SBP 2.5 mg/dL (221 µmol/L); d) Angioneurotic oedema; e) Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with only one kidney; g) Mitral or aortic stenosis; h) Thrombocytopenia, leucopenia, agranulocytosis; i) Hemorrhagic diseases, disease that may give bleeding (i.e. gastric ulcer); j) Acute stroke; k) LES and/or systemic sclerodermia; l) Concomitant chronic anticoagulant treatment; m) Patients undergoing primary PTCA with combined antiplatelet therapy including Clopidogrel + ASA; n) Patients in which a PTCA is planned in the next months due to cardiac conditions; o) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; p) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of Zofenopril associated to ASA at different doses, on the prevention of cardiovascular mortality and morbidity in comparison with Ramipril associated to ASA. ; Secondary Objective: To compare the effects on mortality and morbidity of different doses of ASA given in combination with ACE-inhibitors; to evaluate the individual tolerability of different drug combinations. ;Primary end point(s): 1-year cardiovascular mortality and morbidity (one-year hospitalization for CV causes) | — |
Countries
Ireland, Spain
Outcome results
None listed