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Crestor Versus Placebo in Subjects With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00206310
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)

Condition or disease Intervention/treatment Phase
Heart Failure Drug: CRESTOR Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 5013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Controlled Rosuvastatin Multinational Study in Heart Failure CORONA A Randomized, Double-Blind, Placebo Controlled Phase III Study With Rosuvastatin in Subjects With Chronic Symptomatic Systolic Heart Failure
Study Start Date : September 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to determine whether rosuvastatin reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction (MI) or non-fatal stroke (time to first event).

Secondary Outcome Measures :
  1. The secondary objectives are to evaluate the effects of rosuvastatin on:
  2. Total mortality
  3. Any coronary event defined as the combined endpoint of sudden death or fatal or non-fatal MI or Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) or defibrillation of ventricular fibrillation by an implant
  4. Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
  5. Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator

Exclusion Criteria:

  • Acute myocardial infarction within 6 months before randomization
  • Treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug
Contacts and Locations
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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): NCT00206310


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Medical Science Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00206310    
Other Study ID Numbers: 4522IL/0098
D3562C00098
CORONA
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors