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

14. oktober 2009 opdateret af: Sanofi

Randomized Comparison of a Two-month Regimen of Irbesartan Versus Enalapril on Cardiovascular Markers in Patients With Acute Coronary Syndrome Without ST Segment Elevation.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: Irbesartan

Undersøgelsestype

Interventionel

Tilmelding

440

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Brussels, Belgien
    - Sanofi-Aventis
Canada
- - Laval, Canada
    - Sanofi-Aventis
Det Forenede Kongerige
- - Guildford, Det Forenede Kongerige
    - Sanofi-Aventis
Forenede Stater
- New Jersey
  - Bridgewater, New Jersey, Forenede Stater
    - Sanofi-Aventis
Frankrig
- - Paris, Frankrig
    - Sanofi-Aventis
Holland
- - Gouda, Holland
    - Sanofi-Aventis
Italien
- - Milan, Italien
    - Sanofi-Aventis
Schweiz
- - Meyrin, Schweiz
    - Sanofi-Aventis
Spanien
- - Barcelona, Spanien
    - Sanofi-Aventis
Tyskland
- - Berlin, Tyskland
    - Sanofi-Aventis
Ungarn
- - Budapest, Ungarn
    - Sanofi-Aventis

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria

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)

Exclusion Criteria

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Faktoriel opgave
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
comparison of the relative change from baseline in hsCRP at day 60 between the two treatment groups

Sekundære resultatmål

Resultatmål
Relative change from baseline of hsCRP at discharge
Changes from baseline in BNP and Microalbuminuria (MAU) at discharge and day 60
Change of Troponin I from baseline at discharge
In addition at baseline, discharge and D60 the following parameters will be evaluated and their evolution compared in the two treatment groups: IL6, CD 40 L, sPLA2 and Lp-PLA2, IMA, MMP-9, MPO (myeloperoxydase), aldosterone
Blood pressure at discharge, D15 and D60.
The early versus late (at hospital discharge) initiation of treatment will also be evaluated on the above-listed parameters.
& Safety outcomes

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

Studieleder: Catherine Domenger, MD, Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Montalescot G, Drexler H, Gallo R, Pearson T, Thoenes M, Bhatt DL. Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study. Eur Heart J. 2009 Nov;30(22):2733-41. doi: 10.1093/eurheartj/ehp301. Epub 2009 Aug 21.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2006

Primær færdiggørelse (Faktiske)

1. marts 2007

Datoer for studieregistrering

Først indsendt

22. februar 2006

Først indsendt, der opfyldte QC-kriterier