Heart Failure Clinical Trial
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
| Verified date | November 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 5013 |
| Est. completion date | July 2007 |
| Est. primary completion date | July 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Bouge | |
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Edegem | |
| Belgium | Research Site | Ensival | |
| Belgium | Research Site | Fléron | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Huy | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Mol | |
| Belgium | Research Site | Turnhout | |
| Belgium | Research Site | Verviers | |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Russe | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Czech Republic | Research Site | ¿eská Lípa | |
| Czech Republic | Research Site | ¿eské Bud¿jovice | |
| Czech Republic | Research Site | Bene¿ov | |
| Czech Republic | Research Site | Bene¿ov u Prahy | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Hradec Králové | |
| Czech Republic | Research Site | Hradec Králové 5 | |
| Czech Republic | Research Site | Jihlava | |
| Czech Republic | Research Site | Kladno | |
| Czech Republic | Research Site | Liberec | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Ostrava 1 | |
| Czech Republic | Research Site | Ostrava 3 - Vítkovice | |
| Czech Republic | Research Site | P¿íbram | |
| Czech Republic | Research Site | P¿íbram V - Zdabo¿ | |
| Czech Republic | Research Site | Pelh¿imov | |
| Czech Republic | Research Site | Plze¿ | |
| Czech Republic | Research Site | Plze¿-Bory | |
| Czech Republic | Research Site | Praha 1 | |
| Czech Republic | Research Site | Praha 10 | |
| Czech Republic | Research Site | Praha 2 | |
| Czech Republic | Research Site | Praha 5 | |
| Czech Republic | Research Site | Praha 6 | |
| Czech Republic | Research Site | Slaný | |
| Czech Republic | Research Site | Tábor | |
| Czech Republic | Research Site | Ústí nad Labem | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Esbjerg | |
| Denmark | Research Site | Frederiksberg | |
| Denmark | Research Site | Frederikssund | |
| Denmark | Research Site | Glostrup | |
| Denmark | Research Site | Haderslev | |
| Denmark | Research Site | Helsingør | |
| Denmark | Research Site | Horsens | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | Kbh. S | |
| Denmark | Research Site | København | |
| Denmark | Research Site | København N | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | Kolding | |
| Denmark | Research Site | Næstved | |
| Denmark | Research Site | Odense C | |
| Denmark | Research Site | Roskilde | |
| Denmark | Research Site | Svendborg | |
| Denmark | Research Site | Viborg | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Hyvinkää | |
| Finland | Research Site | Kemi | |
| Finland | Research Site | Kokkola | |
| Finland | Research Site | Lahti | |
| Finland | Research Site | Lappeenranta | |
| Finland | Research Site | Mariehamn | |
| Finland | Research Site | Oulu | |
| Finland | Research Site | Pietarsaari | |
| Finland | Research Site | Porvoo | |
| Finland | Research Site | Seinäjoki | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Uusikaupunki | |
| France | Research Site | Allauch | |
| France | Research Site | Antony | |
| France | Research Site | Arras | |
| France | Research Site | Cambrai Cedex | |
| France | Research Site | Cergy Pontoise | |
| France | Research Site | Chambray Les Tours | |
| France | Research Site | Chantepie | |
| France | Research Site | CHOLET Cedex | |
| France | Research Site | Croix | |
| France | Research Site | Dechy | |
| France | Research Site | Gonesse | |
| France | Research Site | Grenoble Cedex 9 | |
| France | Research Site | Le Coudray | |
| France | Research Site | Lille | |
| France | Research Site | Montfermeil | |
| France | Research Site | Nantes Cedex 2 | |
| France | Research Site | Paris | |
| France | Research Site | Pessac | |
| France | Research Site | Rennes | |
| France | Research Site | Roubaix | |
| France | Research Site | SAINT DENIS Cedex | |
| France | Research Site | Saint Herblain | |
| France | Research Site | Salouel | |
| France | Research Site | Senlis | |
| France | Research Site | Six Fours Les Plages | |
| France | Research Site | Toulouse | |
| France | Research Site | Tourcoing | |
| France | Research Site | Valenciennes | |
| Germany | Research Site | Aachen | |
| Germany | Research Site | Bad Nauheim | |
| Germany | Research Site | Bad Neustadt | |
| Germany | Research Site | Bad Segeberg | Schleswig-Holstein |
| Germany | Research Site | Bad Wörishofen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Brandenburg | |
| Germany | Research Site | Braunschweig | |
| Germany | Research Site | Coburg | |
| Germany | Research Site | Cottbus | |
| Germany | Research Site | Cottbus | Brandenburg |
| Germany | Research Site | Dillingen | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Dresden | Sachsen |
| Germany | Research Site | Düsseldorf | Nordrhein-Westfalen |
| Germany | Research Site | Erfurt | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Esslingen | |
| Germany | Research Site | Frankfurt | Hessen |
| Germany | Research Site | Görlitz | |
| Germany | Research Site | Göttingen | |
| Germany | Research Site | Göttingen | Niedersachsen |
| Germany | Research Site | Greifswald | Mecklenburg-Vorpommern |
| Germany | Research Site | Greifswald | |
| Germany | Research Site | Halle | Sachsen-Anhalt |
| Germany | Research Site | Halle | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hannover | Niedersachsen |
| Germany | Research Site | Jena-Maua | Thüringen |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Leipzig | Sachsen |
| Germany | Research Site | Leisnig | |
| Germany | Research Site | Löbau | |
| Germany | Research Site | Lübeck | |
| Germany | Research Site | Lübeck | Schleswig-Holstein |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | München | |
| Germany | Research Site | München | Bayern |
| Germany | Research Site | Neustadt/Aisch | |
| Germany | Research Site | Norderstedt | |
| Germany | Research Site | Nordhorn | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Regensburg | Bayern |
| Germany | Research Site | Riesa | |
| Germany | Research Site | Rüdersdorf | |
| Germany | Research Site | Saarbrücken | Saarland |
| Germany | Research Site | Stuttgart | Baden-Württemberg |
| Germany | Research Site | Timmendorfer Strand | |
| Germany | Research Site | Tübingen | |
| Germany | Research Site | Vechta | |
| Germany | Research Site | Wedel | |
| Germany | Research Site | Wermsdorf | |
| Germany | Research Site | Wolmirstedt | |
| Hungary | Research Site | Balatonfüred | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Cegléd | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Kecskemét | |
| Hungary | Research Site | Mosonmagyaróvár | |
| Hungary | Research Site | Sopron | |
| Hungary | Research Site | Székesfehérvár | |
| Hungary | Research Site | Szentes | |
| Hungary | Research Site | Szolnok | |
| Ireland | Research Site | Ballinasloe | Co. Galway |
| Ireland | Research Site | Dublin 8 | |
| Ireland | Research Site | Ryhope, SUNDERLAND | |
| Netherlands | Research Site | Alkmaar | |
| Netherlands | Research Site | Almelo | |
| Netherlands | Research Site | Amersfoort | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Apeldoorn | |
| Netherlands | Research Site | Blaricum | |
| Netherlands | Research Site | Breda | |
| Netherlands | Research Site | Capelle Aan Den Ijssel | |
| Netherlands | Research Site | Delft | |
| Netherlands | Research Site | Den Bosch | |
| Netherlands | Research Site | Den Haag | |
| Netherlands | Research Site | Den Helder | |
| Netherlands | Research Site | Deventer | |
| Netherlands | Research Site | Dirksland | |
| Netherlands | Research Site | Dordrecht | |
| Netherlands | Research Site | EDE | |
| Netherlands | Research Site | Enschede | |
| Netherlands | Research Site | Goes | |
| Netherlands | Research Site | Gorinchem | |
| Netherlands | Research Site | Gouda | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Haarlem | |
| Netherlands | Research Site | Hardenberg | |
| Netherlands | Research Site | Heerenveen | |
| Netherlands | Research Site | Heerlen | |
| Netherlands | Research Site | Helmond | |
| Netherlands | Research Site | Hengelo | |
| Netherlands | Research Site | Hilversum | |
| Netherlands | Research Site | Hoofddorp | |
| Netherlands | Research Site | Leiden | |
| Netherlands | Research Site | Lelystad | |
| Netherlands | Research Site | Maastricht | |
| Netherlands | Research Site | Nijmegen | |
| Netherlands | Research Site | OSS | |
| Netherlands | Research Site | Roermond | |
| Netherlands | Research Site | Roosendaal | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Schiedam | |
| Netherlands | Research Site | Sittard | |
| Netherlands | Research Site | Sneek | |
| Netherlands | Research Site | Tiel | |
| Netherlands | Research Site | Tilburg | |
| Netherlands | Research Site | Veldhoven | |
| Netherlands | Research Site | Velp | |
| Netherlands | Research Site | Venlo | |
| Netherlands | Research Site | Zeist | |
| Netherlands | Research Site | Zoetermeer | |
| Netherlands | Research Site | Zwolle | |
| Norway | Research Site | Arendal | |
| Norway | Research Site | Drammen | |
| Norway | Research Site | Flekkefjord | |
| Norway | Research Site | Førde | |
| Norway | Research Site | Fredrikstad | |
| Norway | Research Site | Gjettum | |
| Norway | Research Site | Gjøvik | |
| Norway | Research Site | Hamar | |
| Norway | Research Site | Lillehammer | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Porsgrunn | |
| Norway | Research Site | Tromsø | |
| Poland | Research Site | ¿ód¿ | |
| Poland | Research Site | ¿yrardów | |
| Poland | Research Site | Bia¿ystok | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Chojnice | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gliwice | |
| Poland | Research Site | I¿awa | |
| Poland | Research Site | Inowroc¿aw | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kielce | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | O¿awa | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Ostrowiec ¿wi¿tokrzyski | |
| Poland | Research Site | Piotrków Trybunalski | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Ruda ¿l¿ska | |
| Poland | Research Site | Siedlce | |
| Poland | Research Site | Skierniewice | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Zabrze | |
| Poland | Research Site | Zamo¿¿ | |
| Portugal | Research Site | Almada | |
| Portugal | Research Site | Amadora | |
| Portugal | Research Site | Barreiro | |
| Portugal | Research Site | Carnaxide | |
| Portugal | Research Site | Coimbra | |
| Portugal | Research Site | Funchal | |
| Portugal | Research Site | Lisboa | |
| Portugal | Research Site | Penafiel | |
| Portugal | Research Site | Porto | |
| Portugal | Research Site | Vila Franca de Xira | |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Cluj-Napoca | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Targu-Mures | |
| Russian Federation | Research Site | Moscow | Russia |
| Slovakia | Research Site | Bardejov | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Dolný Kubín | |
| Slovakia | Research Site | Ko¿ice | |
| Slovakia | Research Site | Lu¿enec | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Nové Zámky | |
| Slovakia | Research Site | Pre¿ov | |
| Slovakia | Research Site | Rimavská Sobota | |
| South Africa | Research Site | Bloemfontein | Free State |
| South Africa | Research Site | Bloemfontein | |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | KwaZulu Natal |
| South Africa | Research Site | Lyttelton Manor | |
| South Africa | Research Site | Parktown | |
| South Africa | Research Site | Somerset West | Western Cape |
| South Africa | Research Site | Soweto | Gauteng |
| South Africa | Research Site | Tygerberg | |
| Spain | Research Site | A Coruña | Galicia |
| Spain | Research Site | Alcorcón | Madrid |
| Spain | Research Site | Badalona | Barcelona |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Castellón | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
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| Spain | Research Site | Palma de Mallorca | |
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| Spain | Research Site | San Juan | Alicante |
| Spain | Research Site | San Sebastián | Guipuzcoa |
| Spain | Research Site | Santander | |
| Spain | Research Site | Santiago | A Coruña |
| Spain | Research Site | Santiago de Compostela | A Coruña |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Terrassa | Barcelona |
| Spain | Research Site | Vigo | Pontevedra |
| Sweden | Research Site | Ängelholm | |
| Sweden | Research Site | Danderyd | |
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| Sweden | Research Site | Enköping | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Hudiksvall | |
| Sweden | Research Site | Jönköping | |
| Sweden | Research Site | Karlstad | |
| Sweden | Research Site | Linköping | |
| Sweden | Research Site | Lund | |
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| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Sweden | Research Site | Västervik | |
| Switzerland | Research Site | Bellinzona | |
| Switzerland | Research Site | Bern | |
| Switzerland | Research Site | Genève 14 | |
| Switzerland | Research Site | Lugano | |
| Switzerland | Research Site | Schlieren | |
| Switzerland | Research Site | Zürich | |
| United Kingdom | Research Site | Aberdeen | |
| United Kingdom | Research Site | Airdrie | Lanarkshire |
| United Kingdom | Research Site | Antrim | Northern Ireland |
| United Kingdom | Research Site | Ayr | |
| United Kingdom | Research Site | Basingstoke | |
| United Kingdom | Research Site | Belfast | |
| United Kingdom | Research Site | Belfast | Northern Ireland |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Bridgend | |
| United Kingdom | Research Site | Bridgend | Wales |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Bristol | |
| United Kingdom | Research Site | Carshalton | |
| United Kingdom | Research Site | Cottingham | Hull |
| United Kingdom | Research Site | Croyden | |
| United Kingdom | Research Site | Croydon | |
| United Kingdom | Research Site | Durham | |
| United Kingdom | Research Site | East Kilbride | |
| United Kingdom | Research Site | Edinburgh | |
| United Kingdom | Research Site | Essex | |
| United Kingdom | Research Site | Essex | London |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Hastings | |
| United Kingdom | Research Site | High Wycombe | |
| United Kingdom | Research Site | Hull | |
| United Kingdom | Research Site | Kent | |
| United Kingdom | Research Site | Kirkcaldy | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | Llantrisant | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Middlesex | |
| United Kingdom | Research Site | Newport | |
| United Kingdom | Research Site | Northumberland | |
| United Kingdom | Research Site | Paisley | |
| United Kingdom | Research Site | Paisley | Renfrewhsire |
| United Kingdom | Research Site | Poole | |
| United Kingdom | Research Site | Ryhope, SUNDERLAND | |
| United Kingdom | Research Site | Scunthorpe | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Sidcup | Kent |
| United Kingdom | Research Site | Sunderland | |
| United Kingdom | Research Site | West Bromwich | |
| United Kingdom | Research Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | The secondary objectives are to evaluate the effects of rosuvastatin on: | |||
| Secondary | Total mortality | |||
| Secondary | 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 | |||
| Secondary | Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure | |||
| Secondary | Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure |
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