Ezetimibe and Atorvastatin Therapy on TCFA

Launched by XIJING HOSPITAL · Oct 26, 2015

Keywords

ClinConnect Summary

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 prima...

Gender

ALL

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:
• • 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