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

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235950
• Other study ID #: D3560L00039
• Status: Completed
• Phase: Phase 4
• First received: October 7, 2005
• Last updated: November 18, 2010
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin or atorvastatin or simvastatin and clopidogrel

Locations

Country	Name	City	State
Sweden	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin
Secondary	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.
Secondary	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.
Secondary	Compare the efficacy of treatment with rosuvastatin with the efficacy of treatment with atorvastatin in reducing LDL-C levels
Secondary	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
Secondary	Compare the titration schedule of rosuvastatin with that of atorvastatin.
Secondary	Determine the safety by evaluating the incidence and severity of adverse events and abnormal laboratory values through 16 weeks of treatment