Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05457582
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2022-07-07
Brief Title:
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention A Randomized Double-Blind Placebo-Controlled Parallel-Group Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
SHAWN
Brief Summary:
The primary objective was to evaluate the effect of PCSK 9 Inhibitor initiated within 4 h from PCI for the culprit lesion with high-intensity statin treatment compared to placebo with high-intensity statin treatment on cardiovascular events including cardiovascular death myocardial infarction stroke re-hospitalization due to acute coronary syndromes or heart failure or any ischemia-driven coronary revascularization in patients with acute coronary syndrome and multiple lesions
Detailed Description:
Patients with acute coronary syndrome ACS are at high-risk ACS patients are commonly associated with multiple lesions or multivessel disease Percutaneous coronary intervention PCI is an effective treatment for culprit lesions in ACS Statin at high-intensity is recommended by current guidelines in order to preventslow the progression of non-culprit disease or restenosis PCSK9 inhibitor serves as the most powerful medication in lowering LDL via promoting the expression of LDL receptors in the liver However if the combination of PCSK9 inhibitor with high-intensity statin treatment could significantly reduce the cardiovascular events in patients with ACS who underwent PCI remains unknown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None