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

AstraZeneca214 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

214

Conditions

Hypercholesteremia

Interventions

RosuvastatinDRUG

2.5-20 mg

HMG CoA inhibitorDRUG

3-hydroxy-3-methylglutaryl-coenzyme A

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (27)

Research Site

Gifu, Japan

Research Site

Hamada, Japan

Outcomes

Primary Outcomes

Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)

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.

Time frame: Baseline and 76 weeks

Secondary Outcomes

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

Target Lesion indicates Coronary plaque composition of culprit lesions.

Time frame: Baseline - 76Weeks

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

Time frame: Baseline - 76Weeks

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

Time frame: Baseline - 76Weeks

Data from ClinicalTrials.gov

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