Crestor Versus Placebo in Subjects With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206310
First received: September 16, 2005
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Heart Failure
Drug: CRESTOR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • The secondary objectives are to evaluate the effects of rosuvastatin on:
  • Total mortality
  • 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
  • Cardiovascular mortality with cause-specific mortality for sudden death; fatal MI; and death from worsening heart failure
  • Total number of hospitalizations for cardiovascular causes; for unstable angina; and for worsening heart failure

Estimated Enrollment: 5013
Study Start Date: September 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206310

  Show 378 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00206310     History of Changes
Other Study ID Numbers: 4522IL/0098, D3562C00098, CORONA
Study First Received: September 16, 2005
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
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 August 25, 2014