Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: atorvastatin; Drug: atorvastatin plus ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT01086020

RJH20100101

Details and patient eligibility

About

Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to receive the coronary angiography and potential PCI therapy

Exclusion criteria

• Patients was treated by statins before randomization
• Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
• ST elevation myocardial infarction less than 7 days
• Without informed consent
• Abnormal liver function before randomization, (AST, ALT ≥ULN)
• Active hepatitis or muscular disease
• Impaired renal function with serum creatinine level > 3mg/dl
• Impaired left ventricular function with LVEF > 30%
• Participate in other studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

atorvastatin

Active Comparator group

Description:

patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years

Treatment:

Drug: atorvastatin

atorvastatin and ezetimibe

Experimental group

Description:

patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years

Treatment:

Drug: atorvastatin plus ezetimibe