Study population: Subjects undergoing a primary percutaneous coronary intervention (PCI) to be performed within 6 hours after the onset of symptoms of a first acute anterior myocardial infarction (MI). According to current standards of care, all subjects will have the PCI started less than 6 hours after the onset of the symptoms of AMI.
Conditions
Interventions
Trade Name: Zofil (zofenopril)
Product Name: Zofenil
Product Code: PA0865
Pharmaceutical Form: Tablet
INN or Proposed INN: Zofenopril
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Clinical Research Facilities
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects undergoing a primary percutaneous coronary intervention (PCI) for a first acute anterior myocardial infarction. Subjects between 18 and 75 years of age (inclusive) Written informed consent for participation in 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: Significant cardiac valve disease Significant rhythm disorders Use of ACE-inhibitors prior to myocardial infarction Use of Angiotensin receptor blockers prior to myocardial infarction Risk on serious depression of hemodynamics due to vasodilatation Serum creatinine > 177 mmol/l Hemodialysis ASAT or ALAT > 3 times upper limit Potassium levels > 5.0 mmol/l Pregnancy Fertile female, unless adequately protected with contraceptives Breast-feeding Known intolerance to ACE-inhibitors Cardiogenic shock (Killip class 4) Systolic BP < 100 mmHg History of congestive heart failure History of angio-edema Bilateral renal artery stenoses, or unilateral renal artery stenoses in 1 kidney subjects Subjects treated with antidiabetics, NSAID’s, lithium, potassium saving diuretics, potassium supplements Subjects treated with high doses of diuretics within 24 hrs prior to hospitalization Diabetes mellitus Aortastenosis Any other medical condition that may interfere with the objective of the study according to the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives: 1. To compare the effects of zofenopril and lisinopril on neurohormonal parameters. 2. To compare the difference between early (24 and 24 and <48 hours) treatment with ACE inhibitors on left ventricular function and remodeling. ;Main Objective: Primary objective: To compare the effects of zofenopril and lisinopril on oxidative stress as measured by peak urinary concentrations of malonyldialdehyde ;Primary end point(s): Primary objective: To compare the effects of zofenopril and lisinopril on oxidative stress as measured by peak urinary concentrations of malonyldialdehyde | — |
Countries
Ireland
Outcome results
None listed