Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00235950

Purpose

The purpose of this study is to compare the efficacy between two lipid lowering treatments, rosuvastatin (10-40 mg) and atorvastatin (20-80 mg) in reducing low-density lipoprotein cholesterol (LDL-C) levels after 16 weeks of treatment in patients with coronary heart disease

Condition	Intervention	Phase
Coronary Heart Disease	Drug: Rosuvastatin or atorvastatin or simvastatin and clopidogrel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
Official Title:	A Multicentre Study Comparing the Efficacy of Rosuvastatin With Atorvastatin When Given for a Period of 16 Wks to Subjects With Coronary Heart Disease & a Previously Performed Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Simvastatin Clopidogrel Clopidogrel Bisulfate Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin

Secondary Outcome Measures:

Compare the impact of treatment with rosuvastatin to that of atorvastatin and simvastatin on clopidogrel initiated inhibition of platelet aggregation in a subset of subjects recruited in the Stockholm region.
Compare the impact of treatment with rosuvastatin to that of atorvastatin on clopidogrel initiated inhibition of platelet aggregation in all subjects, totally and on each dose of rosuvastatin and atorvastatin.
Compare the efficacy of treatment with rosuvastatin with the efficacy of treatment with atorvastatin in reducing LDL-C levels
Compare the efficacy of once daily treatment with rosuvastatin with that of atorvastatin in modifying levels of TC, HDL-C, TG, nonHDL-C (TC-HDL-C), LDL-C
Compare the titration schedule of rosuvastatin with that of atorvastatin.
Determine the safety by evaluating the incidence and severity of adverse events and abnormal laboratory values through 16 weeks of treatment

Estimated Enrollment:	255
Study Start Date:	January 2004
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Crestor

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older, established coronary heart disease with a previously performed PCI, previous treatment with clopidogrel, ongoing statin treatment, LDL-C>2.9 mmol/L, signed informed consent.

Exclusion Criteria:

Ongoing treatment with clopidogrel for more than 12 weeks after randomisation, hypersensitivity to any of the study drugs, active liver disease, moderate or severe renal impairment, hereditary for or known muscular or neuromuscular disease and/or increased serum CK, pregnancy or lactation or of childbearing potential not practising an adequate method of contraception, use of concomitant medication with possible interaction with

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235950

Locations

Sweden
Research Site
Danderyd, Sweden
Research Site
Eksjö, Sweden
Research Site
Falun, Sweden
Research Site
Göteborg, Sweden
Research Site
Helsingborg, Sweden
Research Site
Jönköping, Sweden
Research Site
Karlskrona, Sweden
Research Site
Karlstad, Sweden
Research Site
Ljungby, Sweden
Research Site
Lund, Sweden
Research Site
Malmö, Sweden
Research Site
Skövde, Sweden
Research Site
Stockholm, Sweden
Research Site
Sundsvall, Sweden
Research Site
Uppsala, Sweden
Research Site
Västerås, Sweden
Research Site
Växjö, Sweden
Research Site
Örebro, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Medical Science Director, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00235950 History of Changes
Other Study ID Numbers:	D3560L00039
Study First Received:	October 7, 2005
Last Updated:	November 18, 2010
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Coronary Heart Disease
Percutaeous Coronary Intervention (PCI)

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Simvastatin
Atorvastatin
Rosuvastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012