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Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction: a Muti-center, Open-label, Randomized Controlled Trial
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai Municipality, China
Shanghai chest hospital
Shanghai, Shanghai Municipality, China
Shanghai tongren hospital
Shanghai, Shanghai Municipality, China
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai Municipality, China
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Start Date
October 1, 2022
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2026
Last Updated
January 27, 2026
160
ESTIMATED participants
alirocumab
DRUG
conventional treatment
OTHER
Lead Sponsor
Shanghai Tong Ren Hospital
Collaborators
NCT06744322
NCT06788275
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06118281