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

Primary Purpose

Hypercholesteremia

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rosuvastatin
HMG CoA inhibitor
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesteremia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Target Lesion indicates Coronary plaque composition of culprit lesions.
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points

Full Information

First Posted
May 22, 2006
Last Updated
August 29, 2011
Sponsor
AstraZeneca
Collaborators
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT00329160
Brief Title
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Shionogi

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesteremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
2.5-20 mg
Intervention Type
Drug
Intervention Name(s)
HMG CoA inhibitor
Intervention Description
3-hydroxy-3-methylglutaryl-coenzyme A
Primary Outcome Measure Information:
Title
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Description
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.
Time Frame
Baseline and 76 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Description
Target Lesion indicates Coronary plaque composition of culprit lesions.
Time Frame
Baseline - 76Weeks
Title
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Time Frame
Baseline - 76Weeks
Title
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Time Frame
Baseline - 76Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masunori Matsuzaki, MD
Organizational Affiliation
Yamaguchi University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Gifu
Country
Japan
Facility Name
Research Site
City
Hamada
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Ichinomiya
Country
Japan
Facility Name
Research Site
City
Inba-mura
Country
Japan
Facility Name
Research Site
City
Izumisano
Country
Japan
Facility Name
Research Site
City
Izumi
Country
Japan
Facility Name
Research Site
City
Izumo
Country
Japan
Facility Name
Research Site
City
Kagoshima
Country
Japan
Facility Name
Research Site
City
Kanazawa
Country
Japan
Facility Name
Research Site
City
Kasuga
Country
Japan
Facility Name
Research Site
City
Kobe
Country
Japan
Facility Name
Research Site
City
Komaki
Country
Japan
Facility Name
Research Site
City
Konan-cho
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Kurume
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Omiya
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Sapporo
Country
Japan
Facility Name
Research Site
City
Shinjo
Country
Japan
Facility Name
Research Site
City
Shunan
Country
Japan
Facility Name
Research Site
City
Suita
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan
Facility Name
Research Site
City
Ube
Country
Japan
Facility Name
Research Site
City
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22831708
Citation
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. doi: 10.1186/1475-2840-11-87.
Results Reference
derived

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

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