Ezetimibe and Atorvastatin Therapy on TCFA

Xijing Hospital100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

Ezetimibe and AtorvastatinDRUG

atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）

AtorvastatinDRUG

atorvastatin (20 mg/day）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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: 1. administration of lipid-lowering drugs other than statins before enrollment 2. significant stenotic lesions in all coronary vessels 3. severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction\<35% 4. 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 5. renal failure (serum creatinine\>2.0 mg/dL） 6. hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe 7. Others: terminal stage cancer,a positive pregnancy test

Locations (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

minimum fibrous cap thickness

The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.

Time frame: 12months

Central Contacts

Dongdong Sun, M.D., Ph.D.

CONTACT

86 29 84775183 51483696@qq.com

Data from ClinicalTrials.gov

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