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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01040936
First received: December 29, 2009
Last updated: June 14, 2011
Last verified: February 2011
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: Yes ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01040936

Contacts
Contact: Qi Zhang, MD +862164370045 ext 665380 zhangqnh@yahoo.com
Contact: Xin Chen, MD +862164370045 ext 665215 rjchenxin@yahoo.com.cn

Locations
China, Shanghai
Ruijin Hospital, Dept. of Cardiology Recruiting
Shanghai, Shanghai, China, 200025
Contact: Xin Chen, MD    +862164370045 ext 665215    rjchenxin@yahoo.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Wei Feng Shen, MD, PhD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Wei Feng Shen, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01040936     History of Changes
Other Study ID Numbers: RJH-091228, RJH-2009
Study First Received: December 29, 2009
Last Updated: June 14, 2011
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
acute coronary syndrome
intervention
outcome
patients diagnosed ad Non-ST elevation ACS
patients received PCI therapy

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014