Ezetimibe and Atorvastatin Therapy on TCFA

Study Overview
=================
Brief Summary
-----------------
After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.

Detailed Description
-----------------
This is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(TCFA). After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.The secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. Then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.

Official Title
-----------------
Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Ezetimibe and Atorvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level >220 mg/dl (5.7mmol/L) and/or LDL-C level >140 mg/dl(3.6mmol/L), or previously receiving statins therapy 4. the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above Exclusion Criteria: administration of lipid-lowering drugs other than statins before enrollment significant stenotic lesions in all coronary vessels severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction<35% more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction renal failure (serum creatinine>2.0 mg/dL） hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe Others: terminal stage cancer,a positive pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe and Atorvastatin Therapy<br>Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day） | Drug: Ezetimibe and Atorvastatin<br>* atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）<br>* Other names: Ezetrol and lipitor;|
| Active Comparator: Atorvastatin Therapy<br>Atorvastatin (20 mg/day） | Drug: Atorvastatin<br>* atorvastatin (20 mg/day）<br>* Other names: Lipitor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minimum fibrous cap thickness | The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up. | 12months |