Text Size

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
History of Changes
  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:

U.S. FDA Resources

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

  Hide Study Locations
Locations
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, Belgium
Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site
Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Kingston, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Scarborough, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Pointe-claire, Quebec, Canada
Research Site
Saint-charles-borromee, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Canada, Saskatchewan
Research Site
Regina, Saskatchewan, Canada
Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
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, France
Greece
Research Site
Athens, Greece
Hungary
Research Site
Balatonfüred, Hungary
Research Site
Budapest, Hungary
Research Site
Pecs, Hungary
Research Site
Zalaegerszeg, Hungary
Ireland
Research Site
Dublin, Ireland
Research Site
Galway, Ireland
Research Site
Limerick, Ireland
Italy
Research site
Cosenza, Basilicata, Italy
Research Site
Benevento, Campania, Italy
Research Site
Mantova, Lombardia, Italy
Research Site
Rozzano (Milano), Lombardia, Italy
Research Site
Bari, Puglia, Italy
Research Site
Catania, Sicilia, Italy
Research Site
Pisa, Toscana, Italy
Research Site
Perugia, Umbria, Italy
Research Site
Verona, Veneto, Italy
Research Site
Bolzano, Italy
Research Site
Napoli, Italy
Research Site
Padova, Italy
Research Site
Roma, Italy
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, Portugal
Spain
Research Site
Zaragoza, Aragón, Spain
Research Site
Toledo, Castilla la Mancha, Spain
Research Site
Tarragona, Cataluña, Spain
Research Site
San Juan de Alicante, Comunidad Valenciana, Spain
Research Site
Fuenlabrada(Madrid), Madrid, Spain
Research Site
Vigo, Pontevedra, Spain
Research site
Madrid, Spain
Research Site
Sevilla, Spain
Tunisia
Research Site
Bab Saâdoun Tunis, Tunisia
Research Site
Sidi Daoud Tunis, Tunisia
Research Site
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: Directorate general for the protection of Public health: Medicines
Canada: Health Canada
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013