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Completed

NCT Number: NCT00329160

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

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).

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Key information

Conditions

Hypercholesteremia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Gifu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

2.5-20 mg

HMG CoA inhibitor

Drug

3-hydroxy-3-methylglutaryl-coenzyme A

Primary outcomes

  1. 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

  1. Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion

    Time frame: Baseline - 76Weeks

    Target Lesion indicates Coronary plaque composition of culprit lesions.

  2. Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）

    Time frame: Baseline - 76Weeks

  3. Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points

    Time frame: Baseline - 76Weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Shionogi

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 24, 2006
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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