Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
Recruiting now · Phase 4
Conditions studied: Acute Myocardial Infarction
In brief
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.
Key facts
- Study ID
- NCT05292404
- Run by
- Shanghai Tong Ren Hospital
- People needed
- 160
- Starts
- 2022-10-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The age is greater than 18 years old and less than or equal to 80 years old.
- Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
- Signed informed consent.
You may not qualify if…
- Patients who are allergic to PCSK9 inhibitors.
- Multivessel disease planned for selective intervention within half a year.
- Patients who have previously undergone revascularization.
- Pregnant women or women who plan to become pregnant in the next 2 years.
- Patients whose life expectancy is less than 1 year.
- Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
- Known active malignant tumor diseases.
- Patients considered by the investigator to be unsuitable to participate in this study.
Where it is running
- nineth people's hospital, School of Medicine, shanghai jiaotong university — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai chest hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai tongren hospital — Shanghai, Shanghai Municipality, China (enrolling)
- tenth people's hospital, tongji university, Shanghai — Shanghai, Shanghai Municipality, China (enrolling)
- Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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