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
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