Acute Coronary Syndrome Clinical Trial
Official title:
Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS
The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.
| Status | Completed |
| Enrollment | 1160 |
| Est. completion date | October 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion, - Percutaneous coronary intervention (PCI) planned, - Evidence of coronary artery disease Exclusion Criteria: - Hypersensitivity to statins - Any cholesterol lowering medication taken within 1 month prior V1 - Sustained ST-segment elevation on ECG |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Bonheiden | |
| Belgium | Research Site | Bouge | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Huy | |
| Belgium | Research Site | La Louviere | |
| Belgium | Research Site | Leuven | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Pointe-claire | Quebec |
| Canada | Research Site | Regina | Saskatchewan |
| Canada | Research Site | Saint John | New Brunswick |
| Canada | Research Site | Saint-charles-borromee | Quebec |
| Canada | Research Site | Scarborough | Ontario |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | St. John's | Newfoundland and Labrador |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Victoria | British Columbia |
| Canada | Research Site | Winnipeg | Manitoba |
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tartu | |
| France | Research Site | Amiens | |
| France | Research Site | Annecy | |
| France | Research Site | Arras | |
| France | Research Site | Avignon | |
| France | Research Site | Boulogne Billancourt | |
| France | Research Site | Caen | |
| France | Research Site | Cholet | |
| France | Research Site | Creteil | |
| France | Research Site | Dijon | |
| France | Research Site | Eaubonne | |
| France | Research Site | Evecquemont | |
| France | Research Site | Falaise | |
| France | Research Site | La Roche Sur Yon | |
| France | Research Site | LAGNY sur MARNE | |
| France | Research Site | Le Coudray | |
| France | Research Site | Le Mans | |
| France | Research Site | Lille | |
| France | Research Site | Marseille | |
| France | Research Site | Metz | |
| France | Research Site | Montpellier | |
| France | Research Site | Nevers | |
| France | Research Site | Paris | |
| France | Research Site | PAU | |
| France | Research Site | Pessac | |
| France | Research Site | Reims | |
| France | Research Site | Rouen | |
| France | Research Site | Saint-Herblain | |
| France | Research Site | Suresnes | |
| France | Research Site | Toulouse | |
| France | Research Site | Tourcoing | |
| France | Research Site | Tours | |
| France | Research Site | Valenciennes | |
| France | Research Site | Vannes | |
| France | Research Site | Villeurbanne | |
| Greece | Research Site | Athens | |
| Hungary | Research Site | Balatonfüred | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Zalaegerszeg | |
| Ireland | Research Site | Dublin | |
| Ireland | Research Site | Galway | |
| Ireland | Research Site | Limerick | |
| Italy | Research Site | Bari | Puglia |
| Italy | Research Site | Benevento | Campania |
| Italy | Research Site | Bolzano | |
| Italy | Research Site | Catania | Sicilia |
| Italy | Research site | Cosenza | Basilicata |
| Italy | Research Site | Mantova | Lombardia |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Padova | |
| Italy | Research Site | Perugia | Umbria |
| Italy | Research Site | Pisa | Toscana |
| Italy | Research Site | Roma | |
| Italy | Research Site | Rozzano (Milano) | Lombardia |
| Italy | Research Site | Verona | Veneto |
| Portugal | Research Site | Aveiro | |
| Portugal | Research Site | Braga | |
| Portugal | Research Site | Carnaxide | |
| Portugal | Research Site | Faro | |
| Portugal | Research Site | Funchal | |
| Portugal | Research Site | Leiria | |
| Portugal | Research Site | Vila Real | |
| Spain | Research Site | Fuenlabrada(Madrid) | Madrid |
| Spain | Research site | Madrid | |
| Spain | Research Site | San Juan de Alicante | Comunidad Valenciana |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Tarragona | Cataluña |
| Spain | Research Site | Toledo | Castilla la Mancha |
| Spain | Research Site | Vigo | Pontevedra |
| Spain | Research Site | Zaragoza | Aragón |
| Tunisia | Research Site | Bab Saâdoun Tunis | |
| Tunisia | Research Site | Sidi Daoud Tunis | |
| Tunisia | Research Site | Sousse | |
| Tunisia | Research Site | Tunis |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium, Canada, Estonia, France, Greece, Hungary, Ireland, Italy, Portugal, Spain, Tunisia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage changes in ApoB/ApoA-I levels | from Day 0 to 3 months | ||
| Secondary | Percentage changes in LDL-C | from Day 0 to 1 month and 3 months | ||
| Secondary | Percentage changes in the hs-CRP and AUC of hs-CRP levels | from Day -6 to Day 0 | ||
| Secondary | Percentage changes in ApoA-I | from Day 0 to 1 month |
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