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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00235950

Collaborator

(none)

255

Enrollment

Locations

Duration (Months)

14.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Drug: Rosuvastatin or atorvastatin or simvastatin and clopidogrel	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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 Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Compare the efficacy of once daily treatment with rosuvastatin with the efficacy of treatment with atorvastatin []

Secondary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Danderyd	Sweden
2	Research Site	Eksjö	Sweden
3	Research Site	Falun	Sweden
4	Research Site	Göteborg	Sweden
5	Research Site	Helsingborg	Sweden
6	Research Site	Jönköping	Sweden
7	Research Site	Karlskrona	Sweden
8	Research Site	Karlstad	Sweden
9	Research Site	Ljungby	Sweden
10	Research Site	Lund	Sweden
11	Research Site	Malmö	Sweden
12	Research Site	Skövde	Sweden
13	Research Site	Stockholm	Sweden
14	Research Site	Sundsvall	Sweden
15	Research Site	Uppsala	Sweden
16	Research Site	Västerås	Sweden
17	Research Site	Växjö	Sweden
18	Research Site	Örebro	Sweden