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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia, Coronary Artery Disease

Intervention / Treatment
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* Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
* Drug: Lipitor (Atorvastatin) monotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LZ group<br> | Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]<br>* 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.<br>|
| Active Comparator: L group<br> | Drug: Lipitor (Atorvastatin) monotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percentage changes from baseline to follow-up in serum lipids |  | before randomization & 9-12 months after randomization | 
| Correlation between regression of coronary plaque and serum lipids profiles |  | before randomization & 9-12 months after randomization | 
| Changes in hs-CRP from baseline to follow-up |  | 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 | 
| Change and percentage change from baseline to follow-up in the PV of the PCI target lesion |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Diseases, Hyperlipidemia, Atorvastatin, Ezetimibe, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Intravascular Ultrasound