Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05292404
Status:
RECRUITING
Last Update Posted:
2023-11-24
First Post:
2022-03-13
Brief Title:
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Sponsor:
Shanghai Tong Ren Hospital
Organization:
Shanghai Tong Ren Hospital
Study Overview
Official Title:
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction a Muti-center Open-label Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
This is a multi-center prospective randomized controlled study The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group n80 and conventional treatment group n80 using the interactive web response system IWRS at a 11 ratio In the PCSK9 inhibitor group a dose of PCSK9 inhibitor alirocumab was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months the control group received conventional treatment Cardiac Magnetic Resonance Imaging MRI were used to measure myocardial salvage index at 1 week after operation as primary endpoints Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints Serum TnITCKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month 3 months and 6 months after operation Blood inflammation indicators were detected before and 1 week after the operation and 6 months after the operation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None