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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00296387

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 III

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

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

Study ID Numbers:	D3560L00052, CENTAURUS
Study First Received:	February 23, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00296387
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Rosuvastatin
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome

Vascular Diseases
Ischemia
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Syndrome
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009