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

RecruitingPhase 4Ages 18 Years - 75 YearsAllShanghai Tong Ren Hospital
NCT05292404 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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๏ผŒCKMB 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 indi

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. The age is greater than 18 years old and less than or equal to 80 years old. 2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI . 3. Signed informed consent. Exclusion Criteria: 1. Patients who are allergic to PCSK9 inhibitors. 2. Multivessel disease planned for selective intervention within half a year. 3. Patients who have previously undergone revascularization. 4. Pregnant women or women who plan to become pregnant in the next 2 years. 5. Patients whose life expectancy is less than 1 year. 6. Severe liver or kidney dysfunction (ALT\>5 times ULA, eGFR\<15ml/min/1.73m2) 7. Known active malignant tumor diseases. 8. Patients considered by the investigator to be unsuitable to participate in this study.
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What it tests

  • alirocumab
  • conventional treatment
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Where

5 sites
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, China
Shanghai chest hospital
Shanghai, China
Shanghai tongren hospital
Shanghai, China
tenth people's hospital, tongji university, Shanghai
Shanghai, China
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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