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

Study Description

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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 Design

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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

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

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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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daida H, Takayama T, Hiro T, Yamagishi M, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M; COSMOS Investigators. High HbA1c levels correlate with reduced plaque regression during statin treatment in patients with stable coronary artery disease: results of the coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Cardiovasc Diabetol. 2012 Jul 25;11:87.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00329160 History of Changes
Other Study ID Numbers:	D3565L00002; 0407E1841
First Posted:	May 24, 2006
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