Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

NCT ID: NCT01086020

Last Updated: 2011-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

atorvastatin

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

Group Type: ACTIVE_COMPARATOR

atorvastatin

Intervention Type: DRUG

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years

atorvastatin and ezetimibe

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

Group Type: EXPERIMENTAL

atorvastatin plus ezetimibe

Intervention Type: DRUG

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years

Interventions

atorvastatin

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years

Intervention Type: DRUG

atorvastatin plus ezetimibe

Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years

Intervention Type: DRUG

Other Intervention Names

Lipitor; Lipitor and ezetrol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

ruijin hospital, shanghai jiao tong university school of medicine

Principal Investigators

Weifeng Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital,

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ruiyan Zhang, MD

Role: CONTACT

zhangruiyan@263.net

862164370045 ext. 665215

xin Chen, MD

Role: CONTACT

862164370045

Facility Contacts

Ruiyan Zhang, MD

Role: primary

zhangruiyan@263.net

862164370045 ext. 665215

Xin Chen, MD

Role: backup

rjchenxin@yahoo.com.cn

862164370045 ext. 665380

Other Identifiers

RJH20100101

Identifier Type: -

Identifier Source: org_study_id