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Comparison of Rosuvastatin and Atorvastatin in Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT00665834
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Stephen LaHaye, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia Acute Coronary Syndromes Drug: rosuvastatin Drug: placebo Drug: atorvastatin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing LDL-C 1 month and 3 months post PCI. [ Time Frame: 12 weeks ]
  2. 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 ]
  3. Efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-1 ratio at 1 month. [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Stephen LaHaye, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00665834     History of Changes
Other Study ID Numbers: DMED 938-06
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Dyslipidemias
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors