Ezetimibe and Atorvastatin Therapy on TCFA

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Atorvastatin; Drug: Ezetimibe and Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02588235

TCFA-OCT XIJING01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ezetimibe and Atorvastatin Therapy

Experimental group

Description:

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

Treatment:

Drug: Ezetimibe and Atorvastatin

Atorvastatin Therapy

Active Comparator group

Description:

Atorvastatin (20 mg/day）

Treatment:

Drug: Atorvastatin