Crestor Versus Placebo in Subjects With Heart Failure - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206310

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: rosuvastatin	Phase III

MedlinePlus related topics: Heart Attack Heart Failure

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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:	September 2007

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

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

Show 383 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Medical Science Director, MD

AstraZeneca

More Information

Publications indexed to this study:

Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Jánosi A, Kamenský G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61. Epub 2007 Nov 5.

Study ID Numbers:	D3562C00098, CORONA
Study First Received:	September 16, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00206310
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Failure
Rosuvastatin
Heart Diseases
Heart Failure, Systolic

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009