E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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 < 100 mmHg 9) Bilateral stenosis of renal artery 10) Creatinine clairance < or = 30 ml/mn (based on admission serum creatinine value and the Cockcroft formula) 11) Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) class III or IV. 12) Aortic or mitral valve stenosis 13) Hypertrophic cardiomyopathy 14) Connective tissue disease with vascular involvement 15) Angioplasty or surgery or trauma within the last 3 months 16) Coronarography / angioplasty planned to be performed or performed before baseline sampling 17) Febrile disease (≥ 38°C), known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution 18) Hyperkalemia: serum potassium > 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy outcome: comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |