Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02284503
Status:
UNKNOWN
Last Update Posted:
2014-11-06
First Post:
2014-10-30
Brief Title:
Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With Non ST-segment Elevated Acute Coronary SyndromeNSTE-ACS
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A 30-day Randomized Open-Label Multicenter Study Exploring Efficacy of Intensive Rosuvastatin Treatment Peri-PCI in Chinese Patients With NSTE-ACS
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Non ST-segment elevated acute coronary syndromeNSTE-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 ChinaQuite 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 statinsNowadays 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 theres 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None