Effects in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00296387
First received: February 23, 2006
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Rosuvastatin
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage changes in ApoB/ApoA-I levels [ Time Frame: from Day 0 to 3 months ]

Secondary Outcome Measures:
  • Percentage changes in LDL-C [ Time Frame: from Day 0 to 1 month and 3 months ]
  • Percentage changes in the hs-CRP and AUC of hs-CRP levels [ Time Frame: from Day -6 to Day 0 ]
  • Percentage changes in ApoA-I [ Time Frame: from Day 0 to 1 month ]

Estimated Enrollment: 1160
Study Start Date: January 2006
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296387

  Hide Study Locations
Locations
Belgium
Research Site
Aalst, Belgium
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Bonheiden, Belgium
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Bouge, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Hasselt, Belgium
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Huy, Belgium
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La Louviere, Belgium
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Leuven, Belgium
Canada, Alberta
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Edmonton, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, New Brunswick
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Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Scarborough, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-claire, Quebec, Canada
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Saint-charles-borromee, Quebec, Canada
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Sherbrooke, Quebec, Canada
Canada, Saskatchewan
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Regina, Saskatchewan, Canada
Estonia
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Tallinn, Estonia
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Tartu, Estonia
France
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Amiens, France
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Annecy, France
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Arras, France
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Avignon, France
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Boulogne Billancourt, France
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Caen, France
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Cholet, France
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Creteil, France
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Dijon, France
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Eaubonne, France
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Evecquemont, France
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Falaise, France
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La Roche Sur Yon, France
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LAGNY sur MARNE, France
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Le Coudray, France
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Le Mans, France
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Lille, France
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Marseille, France
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Metz, France
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Montpellier, France
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Nevers, France
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Paris, France
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PAU, France
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Pessac, France
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Reims, France
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Rouen, France
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Saint-Herblain, France
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Suresnes, France
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Toulouse, France
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Tourcoing, France
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Tours, France
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Valenciennes, France
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Vannes, France
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Villeurbanne, France
Greece
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Athens, Greece
Hungary
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Balatonfüred, Hungary
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Budapest, Hungary
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Pecs, Hungary
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Zalaegerszeg, Hungary
Ireland
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Dublin, Ireland
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Galway, Ireland
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Limerick, Ireland
Italy
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Cosenza, Basilicata, Italy
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Benevento, Campania, Italy
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Mantova, Lombardia, Italy
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Rozzano (Milano), Lombardia, Italy
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Bari, Puglia, Italy
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Catania, Sicilia, Italy
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Pisa, Toscana, Italy
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Perugia, Umbria, Italy
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Verona, Veneto, Italy
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Bolzano, Italy
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Napoli, Italy
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Padova, Italy
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Roma, Italy
Portugal
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Aveiro, Portugal
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Braga, Portugal
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Carnaxide, Portugal
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Faro, Portugal
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Funchal, Portugal
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Leiria, Portugal
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Vila Real, Portugal
Spain
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Zaragoza, Aragón, Spain
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Toledo, Castilla la Mancha, Spain
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Tarragona, Cataluña, Spain
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San Juan de Alicante, Comunidad Valenciana, Spain
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Fuenlabrada(Madrid), Madrid, Spain
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Vigo, Pontevedra, Spain
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Madrid, Spain
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Sevilla, Spain
Tunisia
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Bab Saâdoun Tunis, Tunisia
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Sidi Daoud Tunis, Tunisia
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Sousse, Tunisia
Research Site
Tunis, Tunisia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00296387     History of Changes
Other Study ID Numbers: D3560L00052, CENTAURUS
Study First Received: February 23, 2006
Last Updated: December 12, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Ireland: Irish Medicines Board
Portugal: National Pharmacy and Medicines Institute
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014