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Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: atorvastatin (Drug); atorvastatin plus ezetimibe (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Shanghai Jiao Tong University School of Medicine

Official(s) and/or principal investigator(s):
Weifeng Shen, MD, Principal Investigator, Affiliation: Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Overall contact:
Ruiyan Zhang, MD, Phone: 862164370045, Ext: 665215, Email: zhangruiyan@263.net

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.

Clinical Details

Official title: Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: change of coronary artery plaque volume

Secondary outcome: composite of adverse cardiac events

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Ruiyan Zhang, MD, Phone: 862164370045, Ext: 665215, Email: zhangruiyan@263.net

Ruijin Hospital,, Shanghai, Shanghai 200025, China; Recruiting
Ruiyan Zhang, MD, Phone: 862164370045, Ext: 665215, Email: zhangruiyan@263.net
Xin Chen, MD, Phone: 862164370045, Ext: 665380, Email: rjchenxin@yahoo.com.cn
Ruiyan Zhang, MD, Principal Investigator
Additional Information

Starting date: January 2010
Last updated: April 1, 2011

Page last updated: August 23, 2015

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