Phase 4
Completed N=214
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Hypercholesteremia
Source: ClinicalTrials.gov NCT00329160 ↗
Enrolled (actual)
214
Serious AEs
46.0%
Results posted
Jul 2011
Primary outcomePrimary: Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) — 14.1 Percent Change
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) |
14.1 | — |
| SECONDARY Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion |
12.074 | — |
| SECONDARY Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C） |
16.9 | — |
| SECONDARY Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points |
18.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00329160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.