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

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, intervention, outcome, patients diagnosed ad Non-ST elevation ACS, patients received PCI therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital, Dept. of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional group

intensive group

Arm Description

patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.

patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.

Outcomes

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.

Secondary Outcome Measures

rate of peri-procedural myocardial infarction
MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization
changes of left ventricular function at 30d after randomization

Full Information

First Posted
December 29, 2009
Last Updated
June 14, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01040936
Brief Title
Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients
Acronym
ILLEPE-ACS
Official Title
Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, intervention, outcome, patients diagnosed ad Non-ST elevation ACS, patients received PCI therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.
Arm Title
intensive group
Arm Type
Experimental
Arm Description
patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
rate of peri-procedural myocardial infarction
Time Frame
30days
Title
MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization
Time Frame
30 days
Title
changes of left ventricular function at 30d after randomization
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Zhang, MD
Phone
+862164370045
Ext
665380
Email
zhangqnh@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Chen, MD
Phone
+862164370045
Ext
665215
Email
rjchenxin@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Feng Shen, MD, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Dept. of Cardiology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Chen, MD
Phone
+862164370045
Ext
665215
Email
rjchenxin@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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