Phase 4 N=214 Treatment

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

Hypercholesteremia

Bottom Line

View on ClinicalTrials.gov: NCT00329160 ↗

Enrolled (actual)

214

Serious AEs

46.0%

Results posted

Jul 2011

Primary outcome: Primary: Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV) — 14.1 Percent Change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rosuvastatin (Drug); HMG CoA inhibitor (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Oct 2008

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	—

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).

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.

View full record on ClinicalTrials.gov →

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.