Pure Global AI
NCT05292404Recruiting

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
Shanghai Tong Ren HospitalPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Acute Myocardial Infarction
Drug/Device/Intervention
alirocumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Tong Ren Hospital
Location
Shanghai,Shanghai,Shanghai,Shanghai, China
Timeline & enrollment
Phase
Phase 4
Start date
Oct 01, 2022
End date
Dec 01, 2024
Enrollment
160 participants
Primary outcome

myocardial salvage index

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 (n=80) and conventional
 treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 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 TnI/T，CKMB 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.

ICD-10 classifications
Acute myocardial infarctionAcute myocardial infarction, unspecifiedAcute subendocardial myocardial infarctionCertain current complications following acute myocardial infarctionOther current complications following acute myocardial infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05292404
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05292404 through Pure Global AI's free database. This Phase 4 trial is sponsored by Shanghai Tong Ren Hospital and is currently Recruiting. The study focuses on Acute Myocardial Infarction. Target enrollment is 160 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.