Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease
Intervention: Rosuvastatin or atorvastatin or simvastatin and clopidogrel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
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
Clinical Details
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
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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, ÖREBRO, 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
Additional Information
Starting date: January 2004
Last updated: May 22, 2006
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