Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

Condition(s) targeted: Hypercholesteremia

Intervention: Rosuvastatin (Drug); HMG CoA inhibitor (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Masunori Matsuzaki, MD, Principal Investigator, Affiliation: Yamaguchi University Hospital

The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2. 5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).

Official title: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-Term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Percentage change from baseline (before the start of rosuvastatin treatment) to Week 76 in the plaque volume (PV)

Secondary outcome:

Change from baseline to Week 76 in PV in the target lesion

Percentage changes from baseline to specified measurement time points in TC, LDL-C, VLDL-C, HDL-C, nonHDL-C, TG and RLP-C

Changes in hs-CRP from baseline to specified measurement time points

Safety; Adverse events, subjective symptoms/objective findings, physical tests), blood tests (hematology, clinical chemistry, glucose metabolism test), urinalysis

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed written informed consent,

- 20 to 75 years old,

- Plan to undergo coronary angiography (CAG) or PCI and LDL-C ≥ 140 mg/dL (untreated

patients) or LDL-C ≥ 100 mg/dL (treated patients)

Exclusion Criteria:

- Acute myocardial infarction within 72 hours after the onset,

- Heart failure of NYHA Class III or above,

- Serious arrhythmia,

- Being treated with LDL-apheresis

- History of serious reaction or hypersensitivity to other HMG-CoA reductase

inhibitors.

Research Site, Sapporo, Japan

Research Site, Shinjo, Japan

Research Site, Inba-mura, Japan

Research Site, Tokyo, Japan

Research Site, Yokohama, Japan

Research Site, Ichinomiya, Japan

Research Site, Komaki, Japan

Research Site, Gifu, Japan

Research Site, Kyoto, Japan

Research Site, Suita, Japan

Research Site, Osaka, Japan

Research Site, Izumisano, Japan

Research Site, Kobe, Japan

Research Site, Hiroshima, Japan

Research Site, Ube, Japan

Research Site, Shunan, Japan

Research Site, Kurume, Japan

Research Site, Kumamoto, Japan

Research Site, IZUMI, Japan

Research Site, Omiya, Japan

Research Site, Kanazawa, Japan

Research Site, Hamada, Japan

Research Site, Izumo, Japan

Research Site, Yamaguchi, Japan

Research Site, Kasuga, Japan

Research Site, Kagoshima, Japan

Research Site, Konan-cho, Japan

Starting date: October 2005
Ending date: October 2008
Last updated: December 12, 2007