Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

Kumamoto University245 enrolled

Overview

The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Hypercholesterolemia Coronary Artery Disease

Interventions

Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]DRUG

Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.

Lipitor (Atorvastatin) monotherapyDRUG

The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written informed consent, * 30 to 85 years old, * Plan to undergo PCI and LDL-C \>= 100 mg/dL Exclusion Criteria: * Familial hypercholesterolemia * Being treated with Zetia (Ezetimibe) * Being treated with Fibrates * Renal insufficiency (serum creatinine \>= 2.0 mg/dl) * Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase \>= 3-folds of standard value in each institute) * Undergoing hemodialysis or peritoneal dialysis * Allergic to Lipitor and/or Zetia * Severe underlying disease * Lack of decision-making capacity * Recognized as inadequate by attending doctor

Locations (1)

Kumamoto University

Kumamoto, Japan