RANDOMIZED COMPARISON OF A TWO-MONTH REGIMEN OF IRBESARTAN VERSUS ENALAPRIL ON CARDIOVASCULAR MARKERS IN PATIENTS WITH ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT ELEVATION. - ARCHIPELAGO

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-002161-36-IT
• Date of registration: 31/01/2006
• Prospective Registration: No
• Primary sponsor: Sanofi-Synthelabo Groupe
• Public title: RANDOMIZED COMPARISON OF A TWO-MONTH REGIMEN OF IRBESARTAN VERSUS ENALAPRIL ON CARDIOVASCULAR MARKERS IN PATIENTS WITH ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT ELEVATION. - ARCHIPELAGO
• Scientific title: RANDOMIZED COMPARISON OF A TWO-MONTH REGIMEN OF IRBESARTAN VERSUS ENALAPRIL ON CARDIOVASCULAR MARKERS IN PATIENTS WITH ACUTE CORONARY SYNDROME WITHOUT ST SEGMENT ELEVATION. - ARCHIPELAGO
• Date of first enrolment: 24/01/2006
• Target sample size: 440
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002161-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany, Hungary, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients male or female 1 Age or to 18 years old 2 Patients 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:
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 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 Patients with dementia. 6 Patients unable to come back at all follow-up visits. RELATED TO THE DISEASE / CONCOMITAMT DISEASES. 7 Persistent ST segment elevation at ECG. 8 Systolic blood pressure 100mmHg. 9 Bilateral stenosis of renal artery. 10 Creatinine clearance or to 30 ml/mn based on admission serum creatinine value and the Cockcroft formula 11 Congestive hearth failure with symptoms consistent with New York Hearth 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 or to 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 expentancy 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, quinapril, and/or any other ACE-I currently or previously in development. 22 Chronic steroid or non steroidal anti inflammatory drugs NSAIDs use. Aspirin is permitted. 23 Treatment with allopurinol or procainamide 24 Concomintant use of potassium sparing diuretics e.g. 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 enrollment and during the course of the study. OTHER EXCLUSION CRITERIA. 28 Prisoners or subjects who are compulsorily detained involuntarily incarcerated for treatment or either a psychiatric or physical e.g., infectious disease illness must not be enrolled into this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

ACUTE CORONARY SYNDROME
MedDRA version: 6.1 Level: PT Classification code 10051592

Intervention(s)

Trade Name: IRBESARTAN
Pharmaceutical Form: Tablet
INN or Proposed INN: Irbesartan
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Pharmaceutical Form: Tablet
INN or Proposed INN: Enalapril
CAS Number: 138402-11-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 ENALAPRIL

Primary end point(s): Primary efficacy outcome comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups.

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.

Secondary ID(s)

PM-C-0024

2005-002161-36-GB