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

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Atorvastatin

• Registration Number: NCT01040936
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 available

Study Timeline

• Study First Submitted: 2009-12-29
• Study First Submitted QC: 2009-12-29
• Study First Posted: 2009-12-30
• Study Start: 2010-05
• Status Verified: 2011-02
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-15
• Primary Completion: 2011-10
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive group	Atorvastatin	patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.
conventional group	Atorvastatin	patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ruijin Hospital, Dept. of Cardiology; 🇨🇳 Shanghai, Shanghai, China