Crestor Versus Placebo in Subjects With Heart Failure
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
3 other identifiers
interventional
5,013
21 countries
375
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Sep 2003
Typical duration for phase_3 heart-failure
375 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedNovember 19, 2010
November 1, 2010
3.8 years
September 16, 2005
November 17, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (375)
Research Site
Aalst, Belgium
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Bouge, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ensival, Belgium
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Fléron, Belgium
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Genk, Belgium
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Huy, Belgium
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Leuven, Belgium
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Mol, Belgium
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Turnhout, Belgium
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Verviers, Belgium
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Bene¿ov U Prahy, Czechia
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Bene¿ov, Czechia
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Brno, Czechia
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Hradec Králové, Czechia
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Hradec Králové 5, Czechia
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Jihlava, Czechia
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Kladno, Czechia
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Liberec, Czechia
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Ostrava, Czechia
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Ostrava 3 - Vítkovice, Czechia
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Pelh¿imov, Czechia
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Plze¿-Bory, Czechia
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Plze¿, Czechia
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Prague, Czechia
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P¿íbram V - Zdabo¿, Czechia
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P¿íbram, Czechia
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Slaný, Czechia
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Tábor, Czechia
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Ústí nad Labem, Czechia
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¿eská Lípa, Czechia
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¿eské Bud¿jovice, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Elsinore, Denmark
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Esbjerg, Denmark
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Frederiksberg, Denmark
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Frederikssund, Denmark
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Glostrup Municipality, Denmark
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Haderslev, Denmark
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Horsens, Denmark
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Hvidovre, Denmark
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Kbh. S, Denmark
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Kolding, Denmark
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København N, Denmark
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København Ø, Denmark
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Næstved, Denmark
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Odense C, Denmark
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Roskilde, Denmark
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Svendborg, Denmark
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Viborg, Denmark
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Helsinki, Finland
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Hyvinkää, Finland
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Jakobstad, Finland
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Kemi, Finland
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Kokkola, Finland
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Lahti, Finland
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Lappeenranta, Finland
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Mariehamn, Finland
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Oulu, Finland
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Porvoo, Finland
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Seinäjoki, Finland
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Tampere, Finland
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Uusikaupunki, Finland
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Allauch, France
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Antony, France
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Arras, France
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Cambrai, France
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Cergy-Pontoise, France
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Chambray-lès-Tours, France
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Chantepie, France
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Cholet, France
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Croix, France
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Dechy, France
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Gonesse, France
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Grenoble, France
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Le Coudray, France
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Lille, France
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Montfermeil, France
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Nantes, France
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Paris, France
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Pessac, France
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Rennes, France
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Roubaix, France
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Saint-Denis, France
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Saint-Herblain, France
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Salouël, France
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Senlis, France
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Six-Fours-les-Plages, France
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Toulouse, France
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Tourcoing, France
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Valenciennes, France
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Stuttgart, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Cottbus, Brandenburg, Germany
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Hamburg, Hamburg, Germany
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Frankfurt am Main, Hesse, Germany
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Göttingen, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Greifswald, Mecklenburg-Vorpommern, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Saarbrücken, Saarland, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Jena-Maua, Thuringia, Germany
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Aachen, Germany
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Bad Nauheim, Germany
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Bad Neustadt an der Saale, Germany
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Bad Wörishofen, Germany
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Berlin, Germany
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Brandenburg, Germany
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Braunschweig, Germany
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Coburg, Germany
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Cottbus, Germany
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Dillingen, Germany
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Dresden, Germany
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Erfurt, Germany
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Essen, Germany
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Esslingen am Neckar, Germany
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Görlitz, Germany
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Göttingen, Germany
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Greifswald, Germany
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Halle, Germany
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Hamburg, Germany
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Kassel, Germany
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Leipzig, Germany
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Leisnig, Germany
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Löbau, Germany
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Lübeck, Germany
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Mannheim, Germany
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München, Germany
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Neustadt/Aisch, Germany
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Norderstedt, Germany
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Nordhorn, Germany
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Regensburg, Germany
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Riesa, Germany
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Rüdersdorf, Germany
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Timmendorfer Strand, Germany
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Tübingen, Germany
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Vechta, Germany
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Wedel, Germany
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Wermsdorf, Germany
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Wolmirstedt, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Cegléd, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gyula, Hungary
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Kecskemét, Hungary
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Mosonmagyaróvár, Hungary
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Sopron, Hungary
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Szentes, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Ballinasloe, Co. Galway, Ireland
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Dublin, Ireland
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Ryhope, Sunderland, Ireland
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's-Hertogenbosch, Netherlands
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Alkmaar, Netherlands
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Almelo, Netherlands
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Apeldoorn, Netherlands
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Blaricum, Netherlands
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Breda, Netherlands
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Capelle aan den IJssel, Netherlands
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Delft, Netherlands
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Den Helder, Netherlands
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Deventer, Netherlands
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Dirksland, Netherlands
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Dordrecht, Netherlands
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Ede, Netherlands
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Enschede, Netherlands
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Goes, Netherlands
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Gorinchem, Netherlands
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Gouda, Netherlands
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Groningen, Netherlands
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Haarlem, Netherlands
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Hardenberg, Netherlands
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Heerenveen, Netherlands
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Heerlen, Netherlands
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Helmond, Netherlands
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Hengelo, Netherlands
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Hilversum, Netherlands
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Hoofddorp, Netherlands
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Leiden, Netherlands
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Lelystad, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Oss, Netherlands
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Roermond, Netherlands
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Roosendaal, Netherlands
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Rotterdam, Netherlands
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Schiedam, Netherlands
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Sittard, Netherlands
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Sneek, Netherlands
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The Hague, Netherlands
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Tiel, Netherlands
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Tilburg, Netherlands
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Veldhoven, Netherlands
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Velp, Netherlands
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Venlo, Netherlands
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Zeist, Netherlands
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Zoetermeer, Netherlands
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Zwolle, Netherlands
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Arendal, Norway
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Drammen, Norway
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Flekkefjord, Norway
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Fredrikstad, Norway
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Førde, Norway
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Gjettum, Norway
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Gjøvik, Norway
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Hamar, Norway
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Lillehammer, Norway
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Oslo, Norway
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Porsgrunn, Norway
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Tromsø, Norway
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Bialystok, Poland
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Bia¿ystok, Poland
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Bydgoszcz, Poland
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Chojnice, Poland
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Gdansk, Poland
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Gdynia, Poland
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Gliwice, Poland
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Inowroc¿aw, Poland
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I¿awa, Poland
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Katowice, Poland
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Kielce, Poland
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Lodz, Poland
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Lublin, Poland
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Olsztyn, Poland
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Ostrowiec ¿wi¿tokrzyski, Poland
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O¿awa, Poland
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Piotrkow Trybunalski, Poland
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Poznan, Poland
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Ruda ¿l¿ska, Poland
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Siedlce, Poland
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Skierniewice, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Zamo¿¿, Poland
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¿ód¿, Poland
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¿yrardów, Poland
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Almada, Portugal
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Amadora, Portugal
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Barreiro, Portugal
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Carnaxide, Portugal
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Coimbra, Portugal
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Funchal, Portugal
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Lisbon, Portugal
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Penafiel, Portugal
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Porto, Portugal
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Vila Franca de Xira, Portugal
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Târgu Mureş, Romania
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Moscow, Russia, Russia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Dolný Kubín, Slovakia
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Ko¿ice, Slovakia
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Lu¿enec, Slovakia
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Nitra, Slovakia
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Nové Zámky, Slovakia
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Pre¿ov, Slovakia
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Rimavská Sobota, Slovakia
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Bloemfontein, Free State, South Africa
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Soweto, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Somerset West, Western Cape, South Africa
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Bloemfontein, South Africa
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Cape Town, South Africa
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Lyttelton Manor, South Africa
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Parktown, South Africa
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Tygerberg, South Africa
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Santiago, A Coruña, Spain
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Santiago de Compostela, A Coruña, Spain
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San Juan, Alicante, Spain
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Badalona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Santander, Cantabria, Spain
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Castellon, Castellón, Spain
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A Coruña, Galicia, Spain
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San Sebastián, Guipuzcoa, Spain
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Alcorcón, Madrid, Spain
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Madrid, Madrid, Spain
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Marbella, Málaga, Spain
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Málaga, Málaga, Spain
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Palma de Mallorca, Palma de Mallorca, Spain
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Vigo, Pontevedra, Spain
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Salamanca, Salamanca, Spain
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Seville, Sevilla, Spain
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Ängelholm, Sweden
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Danderyd, Sweden
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Eksjö, Sweden
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Enköping, Sweden
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Gothenburg, Sweden
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Hudiksvall, Sweden
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Jönköping, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Lund, Sweden
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Motala, Sweden
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Mölndal, Sweden
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Oskarshamn, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Västervik, Sweden
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Bellinzona, Switzerland
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Bern, Switzerland
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Geneva, Switzerland
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Lugano, Switzerland
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Schlieren, Switzerland
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Zurich, Switzerland
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Cottingham, Hull, United Kingdom
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Sidcup, Kent, United Kingdom
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Airdrie, Lanarkshire, United Kingdom
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Essex, London, United Kingdom
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Antrim, Northern Ireland, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Paisley, Renfrewhsire, United Kingdom
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Bridgend, Wales, United Kingdom
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Aberdeen, United Kingdom
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Ayr, United Kingdom
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Basingstoke, United Kingdom
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Belfast, United Kingdom
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Blackpool, United Kingdom
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Bridgend, United Kingdom
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Brighton, United Kingdom
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Bristol, United Kingdom
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Carshalton, United Kingdom
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Croyden, United Kingdom
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Croydon, United Kingdom
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Durham, United Kingdom
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East Kilbride, United Kingdom
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Edinburgh, United Kingdom
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Essex, United Kingdom
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Glasgow, United Kingdom
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Hastings, United Kingdom
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High Wycombe, United Kingdom
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Hull, United Kingdom
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Kent, United Kingdom
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Kirkcaldy, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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Llantrisant, United Kingdom
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London, United Kingdom
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Middlesex, United Kingdom
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Newport, United Kingdom
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Northumberland, United Kingdom
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Paisley, United Kingdom
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Poole, United Kingdom
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Ryhope, Sunderland, United Kingdom
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Scunthorpe, United Kingdom
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Sheffield, United Kingdom
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Sunderland, United Kingdom
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West Bromwich, United Kingdom
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York, United Kingdom
Related Publications (14)
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.
PMID: 26288364DERIVEDPerez 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.
PMID: 24622117DERIVEDGravning 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.
PMID: 24284025DERIVEDPerez 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.
PMID: 23473415DERIVEDvan 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.
PMID: 23395934DERIVEDAskevold 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.
PMID: 23230311DERIVEDGullestad 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.
PMID: 23194488DERIVEDLatini 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.
PMID: 22740508DERIVEDStein 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.
PMID: 22304793DERIVEDUeland 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.
PMID: 21216833DERIVEDMcMurray 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.
PMID: 20883926DERIVEDInglis 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.
PMID: 20501489DERIVEDMcMurray 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.
PMID: 19917888DERIVEDKjekshus 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.
PMID: 17984166DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 21, 2005
Study Start
September 1, 2003
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
November 19, 2010
Record last verified: 2010-11