Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease
Phase 4
Completed
- Conditions
- Coronary Heart Disease
- Registration Number
- NCT00235950
- Lead Sponsor
- AstraZeneca
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇸🇪Örebro, Sweden