Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06096909
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-09-28
Brief Title:
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
China National Center for Cardiovascular Diseases
Study Overview
Official Title:
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population EMPACT A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
For patients with ACS undergoing PCI intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible that is lower LDL-C level should be achieved as soon as possible Compared with conventional lipid-lowering regimen it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation Therefore the optimization strategy of for patients with ACS undergoing PCI intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible is proposed
Detailed Description:
Atherosclerotic cardiovascular disease ASCVD is the leading cause of death worldwide and its incidence is increasing yearly in China which has not yet reached the inflection point Acute coronary syndrome ACS is a severe form of ASCVD and lipid-lowering and antithrombotic therapy are the two core therapies In the latest ESCEAS guidelines for lipid management for ACS patients the target LDL-C is 14 mmolL and 50 reduction from baseline and specific initiatives to achieve this target are proposed emphasizing the timing of clinical application and status of the novel lipid-lowering agent-proprotein convertase subtilisinkexin type 9 monoclonal antibody PCSK9 hereafter referred to as PCSK9 antibody In recent years large-scale randomized controlled trials and outcomes of PCSK9 antibodies have demonstrated that PCSK9 antibodies further reduce adverse cardiovascular events by significantly lowering LDL-C levels under the background statin cholesterol absorption inhibitor therapy The introduction of PCSK9 antibodies allowed for the reduction of LDL-C to unprecedented levels From the cholesterol principle perspective it is theoretically reasonable to add a PCSK9 inhibitor to statins as soon as possible during hospitalization for ACS patients Still there is no clear evidence from large RCTs Current evidence supports that for ACS patients PCSK9 antibodies could be used only when LDL-C is still not up to standard based on treatment with the maximum tolerable dose of statins during the first 2-3 months However the immediate initiation of PCSK9 antibodies during the acute phase of ACS before hospital discharge has yet to be studied
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?:
False
Is an FDA AA801 Violation?:
None