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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 214
- Locations
- 27
- Primary Endpoint
- Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion(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)