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

Acute Coronary Syndrome Clinical Trial

— ILLEPE-ACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01040936
• Other study ID #: RJH-091228
• Secondary ID: RJH-2009
• Status: Recruiting
• Phase: Phase 4
• First received: December 29, 2009
• Last updated: June 14, 2011
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: February 2011
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Qi Zhang, MD
• Phone: +862164370045
• Email: zhangqnh[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital, Dept. of Cardiology	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	rate of peri-procedural myocardial infarction		30days	Yes
Secondary	MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization		30 days	Yes
Secondary	changes of left ventricular function at 30d after randomization		30 days	Yes