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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Hypercholesterolemia
• Interventions: Drug: Lipitor (Atorvastatin) monotherapy; Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]

• Registration Number: NCT01043380
• Lead Sponsor: Kumamoto University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L group	Lipitor (Atorvastatin) monotherapy	-
LZ group	Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion	before randomization & 9-12 months after randomization

Secondary Outcome Measures

Name	Time	Method
Correlation between regression of coronary plaque and serum lipids profiles	before randomization & 9-12 months after randomization
Percentage changes from baseline to follow-up in serum lipids	before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)	before randomization & 9-12 months after randomization
Changes in hs-CRP from baseline to follow-up	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion	before randomization & 9-12 months after randomization
Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the PV of the PCI target lesion	before randomization & 9-12 months after randomization
MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting])	before randomization & 9-12 months after randomization
All-cause death	before randomization & 9-12 months after randomization
Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)	before randomization & 9-12 months after randomization

Trial Locations

Locations (1)

Kumamoto University; 🇯🇵 Kumamoto, Japan