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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional group<br>patients will be treated by atorvastation 20mg/d after randomization, and continued for one year. | Drug: Atorvastatin<br>* patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year<br>|
| Experimental: intensive group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndrome, intervention, outcome, patients diagnosed ad Non-ST elevation ACS, patients received PCI therapy