Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin

Criteria

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