ARCHIPELAGO: Irbesartan in Patients With Acute Coronary Syndrome Without ST Segment Elevation

Completed · Phase 3

Conditions studied: Myocardial Ischemia, Hypertension

In brief

Primary 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 Objectives * 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.

Key facts

Study ID

NCT00296218

Run by

Sanofi

People needed

440

Starts

2006-02-01

Last updated by the study team

2009-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient hospitalised with ischemic symptoms (last episode within the last 48 hours before randomization) and at least one of the following characteristics of NSTEACS (non-ST-segment-elevation acute coronary syndromes):
• 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)

You may not qualify if…

• Women of child bearing potential 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)
• Women who are pregnant or breast feeding
• Women with a positive pregnancy test on enrolment or prior to study drug administration
• Patient with dementia
• Persistent ST segment elevation at ECG
• Systolic blood pressure < 100 mmHg
• Bilateral stenosis of renal artery
• Creatinine clearance < or = 30ml/mn
• Congestive heart failure with symptoms consistent with New York Heart Association (NYHA) class III or IV.
• Aortic or mitral valve stenosis
• Hypertrophic cardiomyopathy
• Connective tissue disease with vascular involvement
• Angioplasty, surgery or trauma within the last 3 months
• Coronarography or angioplasty planned to be performed or performed before baseline sampling
• Febrile (≥ 38°C) disease, known concomitant viral or bacterial infection, chronic auto immune disease, chronic inflammatory disease, known cancer in evolution
• Hyperkalemia: serum potassium > 5.5mmol/l
• Sensitivity or intolerance to Angiotensin receptor blockers (ARBs) : olmesartan, candesartan, irbesartan, eprosartan, losartan, telmisartan, valsartan and/or any other ARB currently or previously in development.
• Sensitivity or intolerance to Angiotensin-converting Enzyme Inhibitors (ACE-I) : benazepril, captopril, enalapril, lisinopril, trandolapril, ramipril, quinapril, and/or any other ACE-I currently or previously in development.
• Chronic steroid or non-steroidal anti inflammatory drugs (NSAIDs) use. Aspirin is permitted.
• Treatment with allopurinol or procaïnamide
• Concomitant use of potassium sparing diuretics (eg. spironolactone, triamterene or amiloride), potassium preparations or salt substitutes containing potassium
• Treatment with Lithium
• Immunosupressive medication
• Administration of any other investigational drug in the last 30 days before enrolment and during the course of the study
• Treatment with ARB or ACE inhibitor within the last 3 days.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States
• Sanofi-Aventis — Brussels, Belgium
• Sanofi-Aventis — Laval, Canada
• Sanofi-Aventis — Paris, France
• Sanofi-Aventis — Berlin, Germany
• Sanofi-Aventis — Budapest, Hungary
• Sanofi-Aventis — Milan, Italy
• Sanofi-Aventis — Gouda, Netherlands
• Sanofi-Aventis — Barcelona, Spain
• Sanofi-Aventis — Meyrin, Switzerland
• Sanofi-Aventis — Guildford, United Kingdom

Full record on ClinicalTrials.gov

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