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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01040936

RJH-091228

RJH-2009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

conventional group

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin

intensive group

Experimental group

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.

Treatment:

Drug: Atorvastatin

Drug: Atorvastatin