Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction - Trial NCT05292404
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.
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Study Focus
Sponsor & Location
Shanghai Tong Ren Hospital
Timeline & Enrollment
Phase 4
Oct 01, 2022
Dec 01, 2024
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๏ผCKMB 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
Data Source
ClinicalTrials.gov
NCT05292404
Non-Device Trial