For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients. Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
330
Very early use of Rosuvastatin before primary PCI in anterior STEMI
Very early use of Evolocumab before primary PCI in anterior STEMI
The People's Hospital of Gongyi
Gongyi, Henan, China
RECRUITINGKaifeng Central Hospital
Kaifeng, Henan, China
RECRUITINGThe People's Hospital of Changyuan
Xinxiang, Henan, China
RECRUITINGHopeshine Minsheng Hospital of Xinzheng
Xinzheng, Henan, China
RECRUITINGThe People's Hospital of Xuchang
Xuchang, Henan, China
RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGChange in left ventricular ejection fraction (LVEF)
Echocardiography Core Laboratory, blinded analysis
Time frame: Baseline and 12 weeks
Change in left ventricular end diastolic/systolic diameter
Echocardiography Core Laboratory, blinded analysis
Time frame: Baseline and 12 weeks
Change in left ventricular end diastolic/systolic volume
Echocardiography Core Laboratory, blinded analysis
Time frame: Baseline and 12 weeks
A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Time frame: 12 weeks, 52 weeks
Proportion of LDL-C < 1.4 mmol/L
Time frame: One week, 12 weeks
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time frame: TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset
Level of troponin
Time frame: 24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
Number of patients with adverse events and serious adverse events
Time frame: At hospital discharge, an average of 10 days after randomization
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