Acute coronary syndrome
Conditions
Interventions
Trade Name: Aprovel (irbesartan)
Product Name: irbesartan
Product Code: SR 47436
Pharmaceutical Form: Tablet
INN or Proposed INN: irbesa
Sponsors
Sanofi-Aventis Groupe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (male or female) 1) Age = 18 years old 2) Patient hospitalized with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of acute coronary syndrome without persistent ST segment elevation: - ECG ST or T changes (ST depression or transient elevation of at least 1mm or T wave changes in at least 2 leads) - Positive troponin (according to local threshold) 3) Signed written informed consent obtained 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: Related to the patient 1) Women of Child Bearing Potential (WCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study WOCBP using a prohibited contraceptive method (not applicable) 2) Women who are pregnant or breast feeding 3) Women with a positive pregnancy test on enrolment or prior to study drug administration 4) Subjects with inability to follow protocol procedures according to the investigation 5) Patient with dementia 6) Patients unable to come back at all follow-up visits Related to the disease/concomitant diseases 7) Persistent ST segment elevation at ECG 8) Systolic blood pressure 5.5 mmol/l 19) Life expectancy less than one year Related to study drug/concomitant therapy 20) Sensitivity or intolerance to ARBs (olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development) 21) Sensitivity or intolerance to ACE-I (benazepril, captopril, enalapril, lisinopril, trendolapril, ramipril, 22) Chronic steroid or non-steroidal anti inflammatory drugs (NSAIDs) use. Aspirin is permitted. 23) Treatment with allopurinol or procaïnamide 24) Concomitant use of potassium sparing diuretics (eg. spironolactone, triamterene or amiloride), potassium preparations, or salt substitutes containing potassium. 25) Treatment with Lithium 26) Immunosupressive medication 27) Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study. 28) Treatment with ARB or ACE inhibitor within the last 3 days. Other exclusion criterion 29) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie hsCRP), in comparison to a similar regimen of enalapril.; Secondary Objective: To compare both regimens on several other biological parameters which have demonstrated their relevance and their predictive clinical value (ie BNP, microalbuminuria, troponin I …) in this patient population. To compare on the above parameters the early initiation of treatment versus the initiation of treatment at hospital discharge. ;Primary end point(s): Primary efficacy outcome: comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups | — |
Countries
Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed