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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

  Show 102 Study Locations
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 22, 2013