Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
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ClinicalTrials.gov Identifier: NCT00329160 |
Recruitment Status :
Completed
First Posted : May 24, 2006
Results First Posted : July 15, 2011
Last Update Posted : August 31, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesteremia | Drug: Rosuvastatin Drug: HMG CoA inhibitor | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 214 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2005 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

- Drug: Rosuvastatin
2.5-20 mg
- Drug: HMG CoA inhibitor
3-hydroxy-3-methylglutaryl-coenzyme A
- Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) [ Time Frame: Baseline and 76 weeks ]Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.
- Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion [ Time Frame: Baseline - 76Weeks ]Target Lesion indicates Coronary plaque composition of culprit lesions.
- Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein (LDL-C) [ Time Frame: Baseline - 76Weeks ]
- Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points [ Time Frame: Baseline - 76Weeks ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed written informed consent,
- 20 to 75 years old,
- Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (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 New York Heart Association (NYHA) Class III or above,
- Serious arrhythmia,
- Being treated with LDL-apheresis
- History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329160
Japan | |
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Gifu, Japan | |
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Hamada, Japan | |
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Hiroshima, Japan | |
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Ichinomiya, Japan | |
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Inba-mura, Japan | |
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Izumisano, Japan | |
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Izumi, Japan | |
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Izumo, Japan | |
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Kagoshima, Japan | |
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Kanazawa, Japan | |
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Kasuga, Japan | |
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Kobe, Japan | |
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Komaki, Japan | |
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Konan-cho, Japan | |
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Kumamoto, Japan | |
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Kurume, Japan | |
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Kyoto, Japan | |
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Omiya, Japan | |
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Osaka, Japan | |
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Sapporo, Japan | |
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Shinjo, Japan | |
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Shunan, Japan | |
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Suita, Japan | |
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Tokyo, Japan | |
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Ube, Japan | |
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Yamaguchi, Japan | |
Research Site | |
Yokohama, Japan |
Principal Investigator: | Masunori Matsuzaki, MD | Yamaguchi University Hospital |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00329160 |
Other Study ID Numbers: |
D3565L00002 0407E1841 |
First Posted: | May 24, 2006 Key Record Dates |
Results First Posted: | July 15, 2011 |
Last Update Posted: | August 31, 2011 |
Last Verified: | August 2011 |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Hypercholesterolemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |