Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated January 27, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-03-21; most recent amendment 2026-01-23.
Status change: Not Yet Recruiting → Recruiting 2022-08-31
Trial Details
NCT Number NCT05292404
Lead Sponsor Shanghai Tong Ren Hospital
Collaborators: China Cardiovascular Association
Conditions Acute Myocardial Infarction
Enrollment 160 participants
Start Date 2022-10-01
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-27