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

Hypercholesteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329160
• Other study ID #: D3565L00002
• Secondary ID: 0407E1841
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2006
• Last updated: August 29, 2011
• Start date: October 2005
• Est. completion date: October 2008

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesteremia
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Shionogi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)	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.	Baseline and 76 weeks	No
Secondary	Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion	Target Lesion indicates Coronary plaque composition of culprit lesions.	Baseline - 76Weeks	No
Secondary	Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein (LDL-C)		Baseline - 76Weeks	No
Secondary	Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points		Baseline - 76Weeks	No