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

Phase 4

Completed

• Conditions: Hypercholesteremia

• Registration Number: NCT00329160
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2011-03-17
• Results First Submitted QC: 2011-06-16
• Results First Posted: 2011-07-15
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)	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 Outcome Measures

Name	Time	Method
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion	Baseline - 76Weeks	Target Lesion indicates Coronary plaque composition of culprit lesions.
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yokohama, Japan