Actively Recruiting
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Led by Shanghai Tong Ren Hospital · Updated on 2026-01-27
160
Participants Needed
5
Research Sites
217 weeks
Total Duration
On this page
Sponsors
S
Shanghai Tong Ren Hospital
Lead Sponsor
C
China Cardiovascular Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years and less than or equal to 80 years
- Clinically diagnosed with STEMI onset within 24 hours
- Planning to undergo primary percutaneous coronary intervention (PPCI)
- Signed informed consent
You will not qualify if you...
- Allergy to PCSK9 inhibitors
- Multivessel disease planned for selective intervention within 6 months
- Previous revascularization
- Pregnant women or planning pregnancy within 2 years
- Life expectancy less than 1 year
- Severe liver or kidney dysfunction (ALT > 5 times upper limit, eGFR < 15 ml/min/1.73m2)
- Known active malignant tumors
- Considered unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
2
Shanghai chest hospital
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
3
Shanghai tongren hospital
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
4
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
5
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
L
Lei Hou, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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