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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Atorvastatin; Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Dept. of Cardiology
      • Contact: Xin Chen, MD; Phone Number: 665215 +862164370045; Email: rjchenxin@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of peri-procedural myocardial infarction	30days
MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization	30 days
changes of left ventricular function at 30d after randomization	30 days

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Wei Feng Shen, MD, PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: December 29, 2009
• First Submitted That Met QC Criteria: December 29, 2009
• First Posted (Estimate): December 30, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: acute coronary syndrome; outcome; intervention; patients diagnosed ad Non-ST elevation ACS; patients received PCI therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: RJH-091228; RJH-2009 (Other Identifier: RuiJin Hospital, Shanghai Jiaotong University School of Medicine)