Heart FailurePhase 3NCT00206310

Crestor Versus Placebo in Subjects With Heart Failure

A Phase 3 study testing CRESTOR in people with Heart Failure, run by AstraZeneca at 375 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event) Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Heart Failure
What is being tested?: CRESTOR
How many people: 5,013 participants
Where: 375 sitesin 21 countries
Study dates: Sep 2003to Jul 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator

Who cannot join

Acute myocardial infarction within 6 months before randomization
Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug

Trial locations and contacts

375 sites in 21 countries.

Country

City, postcode or hospital

375 sites in 21 countries

Germany56 sites

Research Site
Aachen
Research Site
Bad Nauheim
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Bad Neustadt an der Saale
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Bad Segeberg, Schleswig-Holstein
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Bad Wörishofen
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Berlin, State of Berlin
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Berlin
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Brandenburg
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Braunschweig
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Coburg
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Cottbus, Brandenburg
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Cottbus
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Dillingen
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Dresden, Saxony
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Dresden
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Düsseldorf, North Rhine-Westphalia
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Erfurt
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Essen
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Esslingen am Neckar
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Frankfurt am Main, Hesse
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Görlitz
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Göttingen, Lower Saxony
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Göttingen
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Greifswald, Mecklenburg-Vorpommern
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Greifswald
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Halle, Saxony-Anhalt
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Halle
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Hamburg, Free and Hanseatic City of Hamburg
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Hamburg
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Hanover, Lower Saxony
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Jena-Maua, Thuringia
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Kassel
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Leipzig, Saxony
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Leipzig
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Leisnig
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Löbau
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Lübeck, Schleswig-Holstein
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Lübeck
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Mannheim
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München, Bavaria
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München
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Neustadt/Aisch
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Norderstedt
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Nordhorn
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Regensburg, Bavaria
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Regensburg
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Riesa
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Rüdersdorf
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Saarbrücken, Saarland
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Stuttgart, Baden-Wurttemberg
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Timmendorfer Strand
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Tübingen
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Vechta
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Wedel
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Wermsdorf
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Wolmirstedt

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Netherlands48 sites

Research Site
's-Hertogenbosch
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Alkmaar
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Almelo
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Amersfoort
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Amsterdam
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Apeldoorn
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Blaricum
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Breda
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Capelle aan den IJssel
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Delft
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Den Helder
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Deventer
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Dirksland
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Dordrecht
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Ede
Research Site
Enschede
Research Site
Goes
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Gorinchem
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Gouda
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Groningen
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Haarlem
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Hardenberg
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Heerenveen
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Heerlen
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Helmond
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Hengelo
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Hilversum
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Hoofddorp
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Leiden
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Lelystad
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Maastricht
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Nijmegen
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Oss
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Roermond
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Roosendaal
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Rotterdam
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Schiedam
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Sittard
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Sneek
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The Hague
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Tiel
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Tilburg
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Veldhoven
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Velp
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Venlo
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Zeist
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Zoetermeer
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Zwolle

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United Kingdom44 sites

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Aberdeen
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Airdrie, Lanarkshire
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Antrim, Northern Ireland
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Ayr
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Basingstoke
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Belfast, Northern Ireland
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Belfast
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Blackpool
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Bridgend, Wales
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Bridgend
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Brighton
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Bristol
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Carshalton
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Cottingham, Hull
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Croyden
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Croydon
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Durham
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East Kilbride
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Edinburgh
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Essex, London
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Essex
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Glasgow
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Hastings
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High Wycombe
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Hull
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Kent
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Kirkcaldy
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Leicester
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Liverpool
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Llantrisant
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London
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Middlesex
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Newport
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Northumberland
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Paisley, Renfrewhsire
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Paisley
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Poole
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Ryhope, Sunderland
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Scunthorpe
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Sheffield
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Sidcup, Kent
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Sunderland
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West Bromwich
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York

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France28 sites

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Allauch
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Antony
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Arras
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Cambrai
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Cergy-Pontoise
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Chambray-lès-Tours
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Chantepie
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Cholet
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Croix
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Dechy
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Gonesse
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Grenoble
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Le Coudray
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Lille
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Montfermeil
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Nantes
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Paris
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Pessac
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Rennes
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Roubaix
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Saint-Denis
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Saint-Herblain
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Salouël
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Senlis
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Six-Fours-les-Plages
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Toulouse
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Tourcoing
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Valenciennes

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Poland27 sites

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¿ód¿
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¿yrardów
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Bia¿ystok
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Bialystok
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Bydgoszcz
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Chojnice
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Gdansk
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Gdynia
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Gliwice
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I¿awa
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Inowroc¿aw
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Katowice
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Kielce
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Lodz
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Lublin
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O¿awa
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Olsztyn
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Ostrowiec ¿wi¿tokrzyski
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Piotrkow Trybunalski
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Poznan
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Ruda ¿l¿ska
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Siedlce
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Skierniewice
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Warsaw
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Wroclaw
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Zabrze
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Zamo¿¿

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Czechia21 sites

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¿eská Lípa
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¿eské Bud¿jovice
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Bene¿ov
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Bene¿ov U Prahy
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Brno
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Hradec Králové
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Hradec Králové 5
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Jihlava
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Kladno
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Liberec
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Ostrava
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Ostrava 3 - Vítkovice
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P¿íbram
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P¿íbram V - Zdabo¿
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Pelh¿imov
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Plze¿
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Plze¿-Bory
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Prague
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Slaný
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Tábor
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Ústí nad Labem

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Denmark19 sites

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Aalborg
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Copenhagen
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Elsinore
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Esbjerg
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Frederiksberg
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Frederikssund
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Glostrup Municipality
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Haderslev
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Horsens
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Hvidovre
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Kbh. S
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København N
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København Ø
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Kolding
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Næstved
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Odense C
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Roskilde
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Svendborg
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Viborg

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Spain18 sites

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A Coruña, Galicia
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Alcorcón, Madrid
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Badalona, Barcelona
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Barcelona, Barcelona
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Castellon, Castellón
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Madrid, Madrid
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Málaga, Málaga
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Marbella, Málaga
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Palma de Mallorca, Palma de Mallorca
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Salamanca, Salamanca
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San Juan, Alicante
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San Sebastián, Guipuzcoa
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Santander, Cantabria
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Santiago, A Coruña
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Santiago de Compostela, A Coruña
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Seville, Sevilla
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Terrassa, Barcelona
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Vigo, Pontevedra

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Sweden16 sites

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Ängelholm
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Danderyd
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Eksjö
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Enköping
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Gothenburg
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Hudiksvall
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Jönköping
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Karlstad
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Linköping
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Lund
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Mölndal
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Motala
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Oskarshamn
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Stockholm
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Belgium13 sites

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Aalst
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Bouge
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Bruges
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Brussels
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Edegem
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Ensival
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Fléron
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Genk
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Huy
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Leuven
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Mol
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Turnhout
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Verviers

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Finland13 sites

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Helsinki
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Hyvinkää
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Jakobstad
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Kemi
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Kokkola
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Lahti
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Lappeenranta
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Mariehamn
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Oulu
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Porvoo
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Seinäjoki
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Tampere
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Hungary12 sites

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Budapest
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Debrecen
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Eger
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Gyula
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Kecskemét
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Szolnok

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Norway12 sites

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Arendal
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Drammen
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Førde
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Fredrikstad
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Gjøvik
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Hamar
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Tromsø

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Portugal10 sites

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Almada
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Barreiro
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Lisbon
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Slovakia9 sites

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Bratislava
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Nitra
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Nové Zámky
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Pre¿ov
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South Africa9 sites

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Lyttelton Manor
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Parktown
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Somerset West, Western Cape
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Tygerberg

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Switzerland6 sites

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Bern
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Bulgaria5 sites

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Romania5 sites

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Brasov
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Ireland3 sites

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Ballinasloe, Co. Galway
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Russia1 site

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Moscow, Russia

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About this study

Official title: Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure

Conditions: Heart Failure
Being tested: CRESTOR
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRESTORDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

Secondary outcomes (5)

The secondary objectives are to evaluate the effects of rosuvastatin on:
Total mortality
Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant
Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Jul 2007

First posted21 Sep 2005 (estimated)
Study startSep 2003
Primary completionJul 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 5,013 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00206310
Sponsor's protocol ID: 4522IL/0098
Other IDs: D3562C00098, CORONA
Status last verified: Nov 2010
First submitted: 16 Sep 2005
Last updated: 19 Nov 2010
Results posted: No

Publications

Askevold ET, Gullestad L, Nymo S, Kjekshus J, Yndestad A, Latini R, Cleland JG, McMurray JJ, Aukrust P, Ueland T. Secreted Frizzled Related Protein 3 in Chronic Heart Failure: Analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). PLoS One. 2015 Aug 19;10(8):e0133970. doi: 10.1371/journal.pone.0133970. eCollection 2015.
PubMed 26288364
Perez AC, Jhund PS, Stott DJ, Gullestad L, Cleland JG, van Veldhuisen DJ, Wikstrand J, Kjekshus J, McMurray JJ. Thyroid-stimulating hormone and clinical outcomes: the CORONA trial (controlled rosuvastatin multinational study in heart failure). JACC Heart Fail. 2014 Feb;2(1):35-40. doi: 10.1016/j.jchf.2013.07.008. Epub 2014 Jan 25.
PubMed 24622117
Gravning J, Askevold ET, Nymo SH, Ueland T, Wikstrand J, McMurray JJ, Aukrust P, Gullestad L, Kjekshus J; CORONA Study Group. Prognostic effect of high-sensitive troponin T assessment in elderly patients with chronic heart failure: results from the CORONA trial. Circ Heart Fail. 2014 Jan;7(1):96-103. doi: 10.1161/CIRCHEARTFAILURE.113.000450. Epub 2013 Nov 27.
PubMed 24284025
Perez AC, Jhund P, Preiss D, Kjekshus J, McMurray JJ. Effect of rosuvastatin on fatigue in patients with heart failure. J Am Coll Cardiol. 2013 Mar 12;61(10):1121-2. doi: 10.1016/j.jacc.2012.12.004. No abstract available.
PubMed 23473415
van der Velde AR, Gullestad L, Ueland T, Aukrust P, Guo Y, Adourian A, Muntendam P, van Veldhuisen DJ, de Boer RA. Prognostic value of changes in galectin-3 levels over time in patients with heart failure: data from CORONA and COACH. Circ Heart Fail. 2013 Mar;6(2):219-26. doi: 10.1161/CIRCHEARTFAILURE.112.000129. Epub 2013 Feb 8.
PubMed 23395934
Askevold ET, Nymo S, Ueland T, Gravning J, Wergeland R, Kjekshus J, Yndestad A, Cleland JG, McMurray JJ, Aukrust P, Gullestad L. Soluble glycoprotein 130 predicts fatal outcomes in chronic heart failure: analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Circ Heart Fail. 2013 Jan;6(1):91-8. doi: 10.1161/CIRCHEARTFAILURE.112.972653. Epub 2012 Dec 10.
PubMed 23230311
Gullestad L, Ueland T, Kjekshus J, Nymo SH, Hulthe J, Muntendam P, McMurray JJ, Wikstrand J, Aukrust P. The predictive value of galectin-3 for mortality and cardiovascular events in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Am Heart J. 2012 Dec;164(6):878-83. doi: 10.1016/j.ahj.2012.08.021. Epub 2012 Oct 29.
PubMed 23194488
Latini R, Gullestad L, Masson S, Nymo SH, Ueland T, Cuccovillo I, Vardal M, Bottazzi B, Mantovani A, Lucci D, Masuda N, Sudo Y, Wikstrand J, Tognoni G, Aukrust P, Tavazzi L; Investigators of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) and GISSI-Heart Failure (GISSI-HF) trials. Pentraxin-3 in chronic heart failure: the CORONA and GISSI-HF trials. Eur J Heart Fail. 2012 Sep;14(9):992-9. doi: 10.1093/eurjhf/hfs092. Epub 2012 Jun 27.
PubMed 22740508
Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.
PubMed 22304793
Ueland T, Dahl CP, Kjekshus J, Hulthe J, Bohm M, Mach F, Goudev A, Lindberg M, Wikstrand J, Aukrust P, Gullestad L. Osteoprotegerin predicts progression of chronic heart failure: results from CORONA. Circ Heart Fail. 2011 Mar;4(2):145-52. doi: 10.1161/CIRCHEARTFAILURE.110.957332. Epub 2011 Jan 7.
PubMed 21216833
McMurray JJ, Dunselman P, Wedel H, Cleland JG, Lindberg M, Hjalmarson A, Kjekshus J, Waagstein F, Apetrei E, Barrios V, Bohm M, Kamensky G, Komajda M, Mareev V, Wikstrand J; CORONA Study Group. Coenzyme Q10, rosuvastatin, and clinical outcomes in heart failure: a pre-specified substudy of CORONA (controlled rosuvastatin multinational study in heart failure). J Am Coll Cardiol. 2010 Oct 5;56(15):1196-204. doi: 10.1016/j.jacc.2010.02.075.
PubMed 20883926
Inglis SC, McMurray JJ, Bohm M, Schaufelberger M, van Veldhuisen DJ, Lindberg M, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wedel H, Wikstrand J; CORONA Study Group. Intermittent claudication as a predictor of outcome in patients with ischaemic systolic heart failure: analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure trial (CORONA). Eur J Heart Fail. 2010 Jul;12(7):698-705. doi: 10.1093/eurjhf/hfq070. Epub 2010 May 25.
PubMed 20501489
McMurray JJ, Kjekshus J, Gullestad L, Dunselman P, Hjalmarson A, Wedel H, Lindberg M, Waagstein F, Grande P, Hradec J, Kamensky G, Korewicki J, Kuusi T, Mach F, Ranjith N, Wikstrand J; CORONA Study Group. Effects of statin therapy according to plasma high-sensitivity C-reactive protein concentration in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA): a retrospective analysis. Circulation. 2009 Dec 1;120(22):2188-96. doi: 10.1161/CIRCULATIONAHA.109.849117. Epub 2009 Nov 16.
PubMed 19917888
Kjekshus J, Apetrei E, Barrios V, Bohm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Janosi A, Kamensky G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61. doi: 10.1056/NEJMoa0706201. Epub 2007 Nov 5.
PubMed 17984166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure
ClinicalTrials.gov ID: NCT00206310
Acronym / sponsor ID: 4522IL/0098
Conditions: Heart Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,013 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator

Key exclusion criteria (2 listed)

Acute myocardial infarction within 6 months before randomization
Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CRESTOR	Drug	–

Primary outcome

The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

5 secondary outcomes

The secondary objectives are to evaluate the effects of rosuvastatin on:
Total mortality
Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant
Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
Derived from this study: PubMed 26288364Askevold ET, Gullestad L, Nymo S, Kjekshus J, Yndestad A, Latini R, Cleland JG, McMurray JJ, Aukrust P, Ueland T. Secreted Frizzled Related Protein 3 in Chronic Heart Failure: Analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). PLoS One. 2015 Aug 19;10(8):e0133970. doi: 10.1371/journal.pone.0133970. eCollection 2015.
Derived from this study: PubMed 24622117Perez AC, Jhund PS, Stott DJ, Gullestad L, Cleland JG, van Veldhuisen DJ, Wikstrand J, Kjekshus J, McMurray JJ. Thyroid-stimulating hormone and clinical outcomes: the CORONA trial (controlled rosuvastatin multinational study in heart failure). JACC Heart Fail. 2014 Feb;2(1):35-40. doi: 10.1016/j.jchf.2013.07.008. Epub 2014 Jan 25.
Derived from this study: PubMed 24284025Gravning J, Askevold ET, Nymo SH, Ueland T, Wikstrand J, McMurray JJ, Aukrust P, Gullestad L, Kjekshus J; CORONA Study Group. Prognostic effect of high-sensitive troponin T assessment in elderly patients with chronic heart failure: results from the CORONA trial. Circ Heart Fail. 2014 Jan;7(1):96-103. doi: 10.1161/CIRCHEARTFAILURE.113.000450. Epub 2013 Nov 27.
Derived from this study: PubMed 23473415Perez AC, Jhund P, Preiss D, Kjekshus J, McMurray JJ. Effect of rosuvastatin on fatigue in patients with heart failure. J Am Coll Cardiol. 2013 Mar 12;61(10):1121-2. doi: 10.1016/j.jacc.2012.12.004. No abstract available.
Derived from this study: PubMed 23395934van der Velde AR, Gullestad L, Ueland T, Aukrust P, Guo Y, Adourian A, Muntendam P, van Veldhuisen DJ, de Boer RA. Prognostic value of changes in galectin-3 levels over time in patients with heart failure: data from CORONA and COACH. Circ Heart Fail. 2013 Mar;6(2):219-26. doi: 10.1161/CIRCHEARTFAILURE.112.000129. Epub 2013 Feb 8.
Derived from this study: PubMed 23230311Askevold ET, Nymo S, Ueland T, Gravning J, Wergeland R, Kjekshus J, Yndestad A, Cleland JG, McMurray JJ, Aukrust P, Gullestad L. Soluble glycoprotein 130 predicts fatal outcomes in chronic heart failure: analysis from the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Circ Heart Fail. 2013 Jan;6(1):91-8. doi: 10.1161/CIRCHEARTFAILURE.112.972653. Epub 2012 Dec 10.
Derived from this study: PubMed 23194488Gullestad L, Ueland T, Kjekshus J, Nymo SH, Hulthe J, Muntendam P, McMurray JJ, Wikstrand J, Aukrust P. The predictive value of galectin-3 for mortality and cardiovascular events in the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA). Am Heart J. 2012 Dec;164(6):878-83. doi: 10.1016/j.ahj.2012.08.021. Epub 2012 Oct 29.
Derived from this study: PubMed 22740508Latini R, Gullestad L, Masson S, Nymo SH, Ueland T, Cuccovillo I, Vardal M, Bottazzi B, Mantovani A, Lucci D, Masuda N, Sudo Y, Wikstrand J, Tognoni G, Aukrust P, Tavazzi L; Investigators of the Controlled Rosuvastatin Multinational Trial in Heart Failure (CORONA) and GISSI-Heart Failure (GISSI-HF) trials. Pentraxin-3 in chronic heart failure: the CORONA and GISSI-HF trials. Eur J Heart Fail. 2012 Sep;14(9):992-9. doi: 10.1093/eurjhf/hfs092. Epub 2012 Jun 27.
Derived from this study: PubMed 22304793Stein EA, Vidt DG, Shepherd J, Cain VA, Anzalone D, Cressman MD. Renal safety of intensive cholesterol-lowering treatment with rosuvastatin: a retrospective analysis of renal adverse events among 40,600 participants in the rosuvastatin clinical development program. Atherosclerosis. 2012 Apr;221(2):471-7. doi: 10.1016/j.atherosclerosis.2011.12.011. Epub 2012 Jan 3.
Derived from this study: PubMed 21216833Ueland T, Dahl CP, Kjekshus J, Hulthe J, Bohm M, Mach F, Goudev A, Lindberg M, Wikstrand J, Aukrust P, Gullestad L. Osteoprotegerin predicts progression of chronic heart failure: results from CORONA. Circ Heart Fail. 2011 Mar;4(2):145-52. doi: 10.1161/CIRCHEARTFAILURE.110.957332. Epub 2011 Jan 7.
Derived from this study: PubMed 20883926McMurray JJ, Dunselman P, Wedel H, Cleland JG, Lindberg M, Hjalmarson A, Kjekshus J, Waagstein F, Apetrei E, Barrios V, Bohm M, Kamensky G, Komajda M, Mareev V, Wikstrand J; CORONA Study Group. Coenzyme Q10, rosuvastatin, and clinical outcomes in heart failure: a pre-specified substudy of CORONA (controlled rosuvastatin multinational study in heart failure). J Am Coll Cardiol. 2010 Oct 5;56(15):1196-204. doi: 10.1016/j.jacc.2010.02.075.
Derived from this study: PubMed 20501489Inglis SC, McMurray JJ, Bohm M, Schaufelberger M, van Veldhuisen DJ, Lindberg M, Dunselman P, Hjalmarson A, Kjekshus J, Waagstein F, Wedel H, Wikstrand J; CORONA Study Group. Intermittent claudication as a predictor of outcome in patients with ischaemic systolic heart failure: analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure trial (CORONA). Eur J Heart Fail. 2010 Jul;12(7):698-705. doi: 10.1093/eurjhf/hfq070. Epub 2010 May 25.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Medical Science Director, MD study director

AstraZeneca

375 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CRESTOR in people with Heart Failure, run by AstraZeneca at 375 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 375 sites in Germany, Netherlands, United Kingdom, France, Poland and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00206310, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.