Comparison of Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome - Full Text View

Sponsor:	Queen's University
Collaborator:	AstraZeneca
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00665834

Purpose

This is a 3-month, randomized, parallel-group study with 2 periods, comparing the efficacy and the safety of rosuvastatin 20 mg versus atorvastatin 80 mg in patients with an acute coronary syndrome (ACS).

Condition	Intervention	Phase
Dyslipidemia Acute Coronary Syndromes	Drug: rosuvastatin Drug: placebo Drug: atorvastatin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of the Effect Noted in The Apo/Apo-1 Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome CENTAURUS Study

Resource links provided by NLM:

Drug Information available for: Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

Compare efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in measuring ApoB/ApoA ratio at 3 months in acute coronary syndrome patients receiving the study treatment after percutaneous coronary intervention (PCI). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing LDL-C 1 month and 3 months post PCI. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Efficacy of early-started rosuvastatin 20 mg versus placebo on hs-CRP from admission to start of study treatment post PCI. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-1 ratio at 1 month. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	April 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Rosuvastatin 20 mg versus placebo 20 mg	Drug: rosuvastatin rosuvastatin 20 mg from day 0 to (maximum) day 6 Drug: placebo placebo 20 mg from day 0 to (maximum) day 6
Active Comparator: 2 rosuvastatin 20 mg versus atorvastatin 80 mg	Drug: rosuvastatin rosuvastatin 20 mg from discharge until the end of the study Drug: atorvastatin atorvastatin 80 mg from discharge until the end of the study

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Men or women who are between 18 and 75 years old
Patients diagnosed with non ST elevation - acute coronary syndrome (NSTE-ACS)
Patients with onset of clinical symptoms less than 24 hours prior to their admission for which a PCI is planned or anticipated.

Exclusion Criteria:

Patients with STEMI (ST elevation myocardial infarction-heart attack) and primary PCI planned within 24 hours of admission will not be included.
Patients will not be allowed to have taken any cholesterol-lowering medications during 1 month prior to enrolment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665834

Locations

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Vascular Disease Prevention and Research Centre, Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2

Sponsors and Collaborators

Queen's University

AstraZeneca

Investigators

Principal Investigator:

Stephen A LaHaye, MD

Queen's University

More Information

No publications provided

Responsible Party:	Stephen LaHaye, QUEEN'S UNIVERSITY
ClinicalTrials.gov Identifier:	NCT00665834 History of Changes
Other Study ID Numbers:	DMED 938-06
Study First Received:	April 22, 2008
Last Updated:	April 23, 2008
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Dyslipidemias
Acute Coronary Syndrome
Lipid Metabolism Disorders
Metabolic Diseases
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, 2012