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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
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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).

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Rosuvastatin
    2.5-20 mg
    Drug: HMG CoA inhibitor
    3-hydroxy-3-methylglutaryl-coenzyme A


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein (LDL-C) [ Time Frame: Baseline - 76Weeks ]
  3. 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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Japan
Research Site
Gifu, Japan
Research Site
Hamada, Japan
Research Site
Hiroshima, Japan
Research Site
Ichinomiya, Japan
Research Site
Inba-mura, Japan
Research Site
Izumisano, Japan
Research Site
Izumi, Japan
Research Site
Izumo, Japan
Research Site
Kagoshima, Japan
Research Site
Kanazawa, Japan
Research Site
Kasuga, Japan
Research Site
Kobe, Japan
Research Site
Komaki, Japan
Research Site
Konan-cho, Japan
Research Site
Kumamoto, Japan
Research Site
Kurume, Japan
Research Site
Kyoto, Japan
Research Site
Omiya, Japan
Research Site
Osaka, Japan
Research Site
Sapporo, Japan
Research Site
Shinjo, Japan
Research Site
Shunan, Japan
Research Site
Suita, Japan
Research Site
Tokyo, Japan
Research Site
Ube, Japan
Research Site
Yamaguchi, Japan
Research Site
Yokohama, Japan
Sponsors and Collaborators
AstraZeneca
Shionogi
Investigators
Principal Investigator: Masunori Matsuzaki, MD Yamaguchi University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00329160     History of Changes
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

Additional relevant MeSH terms:
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