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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 7, 2005
Last updated: November 18, 2010
Last verified: November 2010
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 4

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:

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:
    Drug: Rosuvastatin or atorvastatin or simvastatin and clopidogrel
    Other Name: Crestor

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00235950

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
Study Director: AstraZeneca Medical Science Director, MD AstraZeneca
  More Information 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:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Rosuvastatin Calcium
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on October 20, 2016