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Clinical Trials/NCT00329160
NCT00329160CompletedPhase 4

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

AstraZeneca27 sites in 1 country214 target enrollmentStarted: October 1, 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (27)

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