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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
Information provided by:
Shanghai Jiao Tong University School of Medicine Identifier:
First received: December 29, 2009
Last updated: June 14, 2011
Last verified: February 2011
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 Intervention Phase
Acute Coronary Syndrome Drug: Atorvastatin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

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

Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01040936

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

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
Principal Investigator: Wei Feng Shen, MD, PhD Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Wei Feng Shen, Shanghai Jiao Tong University Identifier: NCT01040936     History of Changes
Other Study ID Numbers: RJH-091228
RJH-2009 ( Other Identifier: RuiJin Hospital, Shanghai Jiaotong University School of Medicine )
Study First Received: December 29, 2009
Last Updated: June 14, 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:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 18, 2017