Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI

Study Overview
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Brief Summary
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This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.

Detailed Description
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The study objective is to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. 2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled. The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI. Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

Official Title
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Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)

Conditions
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Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-75 years old Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography Evidence of a personally signed and dated informed consent document Exclusion Criteria: Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography: Experienced STEMI within previous 30 days Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment. Anticipated repeated PCI within 6 months 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) White blood cell < 4×109/L or platelet < 100×109/L 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
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive statin therapy<br>Atorvastatin 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 names: Liptor;|
| Other: Usual care<br>Usual care, but 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>* Other names: Lescol;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedural change of inflammatory biomarkers (hs-CRP) | Post-procedural change of inflammatory biomarkers (hs-CRP) | 24 hours after PCI | 
| Morbidity of CIN | Morbidity of CIN | 48 hours after PCI | 
| 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 after PCI | 
| Adverse events | Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events | 6 months after PCI | 
| 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 after PCI |