Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, Percutaeous Coronary Intervention (PCI)
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
Interventions
DRUGRosuvastatin or atorvastatin or simvastatin and clopidogrel
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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 | — |
| 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 | — |
Countries
Sweden
Outcome results
None listed