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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hypercholesteremia

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: HMG CoA inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|2.5-20 mg|
|Drug: HMG CoA inhibitor|3-hydroxy-3-methylglutaryl-coenzyme A|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） |  | Baseline - 76Weeks | 
| Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points |  | Baseline - 76Weeks |