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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2009

Last Updated Date

June 14, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01040936 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

Drug: Atorvastatin
patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year
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

Study Arm (s)

Active Comparator: conventional group
patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.

Intervention: Drug: Atorvastatin
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.

Intervention: Drug: Atorvastatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

November 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01040936

Other Study ID Numbers ^ICMJE

RJH-091228, RJH-2009

Has Data Monitoring Committee

Yes

Responsible Party

Wei Feng Shen, Shanghai Jiao Tong University

Study Sponsor ^ICMJE

Shanghai Jiao Tong University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wei Feng Shen, MD, PhD

Shanghai Jiao Tong University School of Medicine

Information Provided By

Shanghai Jiao Tong University School of Medicine

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top