Ignite Creation Date:
2024-05-06 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05043740
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-08-29
Brief Title:
PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population
Sponsor:
Second Xiangya Hospital of Central South University
Organization:
Second Xiangya Hospital of Central South University
Study Overview
Official Title:
Effect of PCSK9 Inhibitor on Acute Coronary Syndrome Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population CHOICE Study
Status:
UNKNOWN
Status Verified Date:
2021-09
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:
The study is an open-label multicenter and randomized study The objective of this study is to demonstrate the effect of PCSK9 inhibitor on ACS patients with multivessel disease and relatively low LDL-C levels or LDL-C levels lower than the recommended target
The primary outcome was the rate of major adverse cardiac events CV death non-fatal myocardial infarction documented unstable angina that requires admission into a hospital all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization Non-fatal stroke at 1 year The secondary efficacy endpoints were individual components of the major adverse cardiac events all cause death and the percent change in LDL-C Apo B HDL-C Lpa after treatment
The primary outcome was the rate of major adverse cardiac events CV death non-fatal myocardial infarction documented unstable angina that requires admission into a hospital all coronary revascularization with either PCI or CABG occurring at least 30 days after randomization Non-fatal stroke at 1 year The secondary efficacy endpoints were individual components of the major adverse cardiac events all cause death and the percent change in LDL-C Apo B HDL-C Lpa after treatment
Detailed Description:
None
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