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

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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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:

2.5-20 mg

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):

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
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 Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases Rosuvastatin	Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015