Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Detailed Description
-----------------
This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

Official Title
-----------------
The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Conditions
-----------------
Myocardial Infarction, Unstable Angina

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 years old Patients with clinical diagnosis of ACS Evidence of a personally signed and dated informed consent document Exclusion Criteria: Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment. LDL-C < 1.8mmol/L in patients without statin therapy in 1 months Endstage congestive heart failure, or LVEF < 30% Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL Myopathy or increased creatine kinase (CK>2 UNL) Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L) Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases Pregnancy, lactation, or child bearing potential women without any effective contraception Accompanied with malignant disease or other disease, which cause life expectancy < 6 months Participating in other interventional clinical trails using drugs or devices Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care | Drug: Atorvastatin<br>* Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care<br>|
| Other: Usual care<br>statin dose should not be higher than that described in exclusion criteria. | Drug: Statin<br>* Usual care, but statin dose should not be higher than that described in exclusion criteria<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI |  | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedural change of inflammatory biomarkers (hs-CRP) |  | 24h | 
| Morbidity of CIN |  | 48h | 
| Elevation of ALT, AST and CK | Proportion of patients who experience at least once AST>3UNL，ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment. | 6 months | 
| Number of Participants with Adverse Events | Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events | 6 months | 
| Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events | Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI. | 6 months | 
| serum adiponectin concentration |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction, Unstable Angina