Clinical trial NCT00235950: Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Percutaeous Coronary Intervention (PCI)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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

Primary outcomes:
measure: Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin
Secondary outcomes:
measure: 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.
measure: 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.
measure: Compare the efficacy of treatment with rosuvastatin with the efficacy of treatment with atorvastatin in reducing LDL-C levels
measure: 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
measure: Compare the titration schedule of rosuvastatin with that of atorvastatin.
measure: Determine the safety by evaluating the incidence and severity of adverse events and abnormal laboratory values through 16 weeks of treatment
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Research Site
city: Eksjö
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Ljungby
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Växjö
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Medical Science Director, MD
role: STUDY_DIRECTOR
References: