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Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
This study has been completed.
Sponsor:
AstraZeneca
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
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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 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 ]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 ]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 ]
- Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points [ Time Frame: Baseline - 76Weeks ]
| 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 (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
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
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 | |
| 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
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 |
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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 27, 2017