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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00206310 |
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Date of registration:
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16/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Crestor Versus Placebo in Subjects With Heart Failure
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Scientific title:
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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 |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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5013 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00206310 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Bulgaria
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Hungary
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Ireland
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Netherlands
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Norway
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Poland
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Portugal
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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AstraZeneca Medical Science Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Drug: CRESTOR
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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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
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The secondary objectives are to evaluate the effects of rosuvastatin on:
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Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure
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Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
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Total mortality
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Secondary ID(s)
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CORONA
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D3562C00098
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4522IL/0098
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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