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-DE
• Date of registration: 22/05/2006
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Aventis 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
• 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 factorial 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 = 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:
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.



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

Health Condition(s) or Problem(s) studied

Acute coronary syndrome

Intervention(s)

Trade Name: Aprovel 150 mg tablets
Product Name: irbesartan
Product Code: SR 47436
Pharmaceutical Form: Tablet
INN or Proposed INN: irbesartan
CAS Number: NA
Current Sponsor code: SR 47436
Other descriptive name: NA
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

Trade Name: Enalapril Maleate 10 mg tablets
Product Name: enalapril
Product Code: Not Applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: enalapril
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
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)

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

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 ID(s)

PM-C-0024

2005-002161-36-GB