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Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients (ILLEPE-ACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040936
Recruitment Status : Unknown
Verified February 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : December 30, 2009
Last Update Posted : June 15, 2011
Information provided by:
Shanghai Jiao Tong University School of Medicine

Brief Summary:
PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
Study Start Date : May 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: conventional group
patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.
Drug: Atorvastatin
patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year

Experimental: intensive group
patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.
Drug: Atorvastatin
patients admitted with Non-ST elevation ACS will be loaded with atorvastatin 80mg once, continued with 40mg/d for 30d, then change to 20mg/d, as a regular dose in China

Primary Outcome Measures :
  1. The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. rate of peri-procedural myocardial infarction [ Time Frame: 30days ]
  2. MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization [ Time Frame: 30 days ]
  3. changes of left ventricular function at 30d after randomization [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • finish informed consent
  • age≥18y and under 75y
  • diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
  • willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria:

  • patient was treated by statins before randomization
  • stable angina or ST elevation myocardial infarction
  • without informed consent
  • abnormal liver function before randomization, (AST,ALT≥3ULN)
  • active hepatitis or muscular disease
  • impaired renal function with serum creatinine level > 3mg/dl
  • impaired left ventricular systolic function with LVEF< 30%
  • participating in other studies
  • non-PCI treated patients after coronary angiography will be washed out

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040936

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Contact: Qi Zhang, MD +862164370045 ext 665380
Contact: Xin Chen, MD +862164370045 ext 665215

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China, Shanghai
Ruijin Hospital, Dept. of Cardiology Recruiting
Shanghai, Shanghai, China, 200025
Contact: Xin Chen, MD    +862164370045 ext 665215   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Principal Investigator: Wei Feng Shen, MD, PhD Shanghai Jiao Tong University School of Medicine

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Responsible Party: Wei Feng Shen, Shanghai Jiao Tong University Identifier: NCT01040936    
Other Study ID Numbers: RJH-091228
RJH-2009 ( Other Identifier: RuiJin Hospital, Shanghai Jiaotong University School of Medicine )
First Posted: December 30, 2009    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: February 2011
Keywords provided by Shanghai Jiao Tong University School of Medicine:
acute coronary syndrome
patients diagnosed ad Non-ST elevation ACS
patients received PCI therapy
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors