This is a 30-day, randomized, open-label, 3-arm, parallel-group, multicenter study exploring efficacy of intensive rosuvastatin treatment peri-PCI in Chinese patients with NSTE-ACS.
Non ST-segment elevated acute coronary syndrome(NSTE-ACS) is increasing rapidly, and is more frequent than ST-segment elevated acute coronary syndrome (STE-ACS) now. NSTE-ACS patients sent to early PCI procedure is large and increasing rapidly in China.Quite a few trials have focused on high loading dose statin before PCI to improve cardiovascular outcomes in ACS. In Asian, high loading dose statin therapy showed different outcome. Rosuvastatin (RSV) is one of the most potent statins.Nowadays, quite a few experts think ACS patients undergoing PCI not only need loading dose statin, but also post PCI intensive statin treatment is rather important. Chinese consensus and western guidelines recommend intensive statin treatment in these patients. However, Chinese consensus referred to the western study as there's no relevant intensive statin treatment peri-PCI study in China until now. Thus this study is designed to explore the efficacy of intensive statin treatment peri-PCI (early loading dose-RSV 40 mg or 20mg before PCI and subsequent 20mg post PCI) in periprocedural myocardial injury and 30 days MACE reduction in Chinese NSTE-ACS patients and explore efficacy of 30-day RSV 20 mg post-PCI treatment in lipid profile, inflammatory factors compared with baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,350
The subjects will receive intensive Rosuvastatin before and after PCI
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
myocardial injury reduction
Myocardial injury assessed by creatine kinase-MB. (CK-MB) elevation, defined as a post-procedural elevation of CK-MB values \>3×99th percentile Upper Reference Limit (URL) in patients with normal baseline values \>99th percentile URL or a rise of CK-MB values\>20% if the baseline values are elevated and are stable or falling; or assessed by cTn elevation, defined as a post-procedural elevation of cardiac troponin (cTn) values \>5×99th percentile URL in patients with normal baseline values \>99th percentile URL or a rise of cTn values\>20% if the baseline values are elevated and are stable or falling.
Time frame: 30 days
MACE reduction
Major Adverse Cardiac Events(MACE) event including death, Myocardial infarction(MI), target vessel revascularization, ischemic stroke
Time frame: 30 days
the change of lipid
the change of lipid marker, including Low-density lipoprotein cholesterol(LDL-C), total cholesterol(TC), High-density lipoprotein cholesterol(HDL-C), triglyceride(TG), non-HDL-C, between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.
Time frame: 30 days
the change of hsCRP
The change of inflammatory marker High sensitivity C-reactive protein(hsCRP) between Rosuvastatin 10 mg/day and 20 mg/day treatment at 30 days.
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.