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
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 |
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).
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Shionogi |
Japan,
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 |
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