Comparison between zofenopril and ramipril in combination with ASA on the extent of cardiovascular risk in patients with systolic left ventricular dysfunction after acute myocardial infarction (SMILE IV trial) - MEN/03/ZOF-CHF/001Protocol Final version dated: 23 Dec 2003Amendment No. 1 Final version dated: 01 Jul 2004Amendment No. 2 Final version dated: 26 Apr 2005 - SMILE IV

Active, not recruiting

• Conditions: Systolic left ventricular dysfunction after AMI; MedDRA version: 7.0Level: LLTClassification code 10049694

• Registration Number: EUCTR2004-001150-88-ES
• Lead Sponsor: Menarini International Operation Luxembourg -SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-12
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 896

Inclusion Criteria

At day 1: a) Written informed consent of the patient; b) Male and female aged 18-85 years; c) Patient suffering from ST-segment elevation acute myocardial infarction, during the 24 hours before inclusion in the study, with clinical (i.e. Killip class > 1, and combination with at least one of the following criteria: 31 heart sound or pulmonary congestion on chest X-ray) or echocardiographic (i.e. LVEF < 45%) evidence of systolic LV dysfunction.

At day 5: Patient suffering from ST-segment elevation acute myocardial infarction, during the 24 hours before inclusion in the study, with clinical (i.e. Killip class > 1, and combination with at least one of the following criteria: 31 heart sound or pulmonary congestion on chest X-ray) or echocardiographic (i.e. LVEF < 45%) evidence of systolic LV dysfunction.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

At day 1: a) Ipersensibility to ACEI or ASA; b) Severe hypotension (SBP < 90 mmHg) defined as systolic blood pressure < 90 mmHg, measured twice, with an interval of 1 hour between the two measurements; c) Renal failure with serum creatinine > 2.1 mg/dL (186 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) Occurrence of gastric ulcer in the past 5 years; k) Acute stroke; l) LES and/or systemic sclerodermia; m) Concomitant chronic anticoagulant treatment (i.e. heparin, acenocumarol, anisindione, dicumarol, warfarin, etc.); n) Rescue PTCA; o) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study;
p) If female, not pregnant or lactating. Documentation of a negative pregnancy test for women of childbearing potential is required prior to enrolment. Women of childbearing potential must use a contraceptive method.

At day 5: a) Ipersensibility to ACEI, or ASA; b) Severe hypotension (SBP < 90 mmHg) defined as systolic blood pressure < 90 mmHg, measured twice, with an interval of 1 hour between the two measurements; c) Renal failure with serum creatinine > 2.1 mg/dL (186 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) Occurrence of gastric ulcer in the past 5 years; k)Acute stroke; l) LES and/or systemic sclerodermia; m) Concomitant chronic anticoagulant treatment (i.e. heparin, acenocumarol, anisindione, dicumarol, warfarin, etc.); n) Rescue PTCA; o) Secondary PTCA planned in the next months due to cardiac conditions; p) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; q) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the cardiovascular benefit of the combination of zofenopril + ASA 100 mg/day in comparison to the combination of ramipril + ASA 100 mg/day on cardiovascular event rate in patients with post-MI systolic left ventricular dysfunction. ;Secondary Objective: To evaluate the individual tolerability of different drug combinations.<br>To evaluate changes in left ventricular remodeling<br>;Primary end point(s): 1-year cardiovascular mortality and morbidity (one-year hospitalization for CV causes)