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

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00329160
First received: May 22, 2006
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Hypercholesteremia
Drug: Rosuvastatin
Drug: HMG CoA inhibitor
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion [ Time Frame: Baseline - 76Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points [ Time Frame: Baseline - 76Weeks ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: October 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin
    2.5-20 mg
    Drug: HMG CoA inhibitor
    3-hydroxy-3-methylglutaryl-coenzyme A
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Izumi, Japan
Research Site
Izumisano, 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: May 22, 2006
Results First Received: March 17, 2011
Last Updated: August 29, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014