Non-ST-elevation Acute Coronary Syndromes Clinical Trial
Official title:
A 30-day, Randomized, Open-Label, Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment