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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Hypercholesteremia

Treatments: Drug: HMG CoA inhibitor; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329160

0407E1841

D3565L00002

Details and patient eligibility

About

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).

Enrollment: 214 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)