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Slow patient enrollment and lack of financial support
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive statin group | Active Comparator | Rosuvastatin, 20 mg per day after randomization |
|
| Combined intensive statin and PCSK9 inhibitor group | Experimental | Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization |
|
| PCSK9 inhibitor alone group | Experimental | Evolocumab, 140 mg twice a month after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 20 mg | Drug | Very early use of Rosuvastatin before primary PCI in anterior STEMI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular ejection fraction (LVEF) | Echocardiography Core Laboratory, blinded analysis | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular end diastolic/systolic diameter | Echocardiography Core Laboratory, blinded analysis | Baseline and 12 weeks |
| Change in left ventricular end diastolic/systolic volume | Echocardiography Core Laboratory, blinded analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The People's Hospital of Gongyi | Gongyi | Henan | China | |||
| Kaifeng Central Hospital |
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| Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] | Drug | Very early use of Evolocumab before primary PCI in anterior STEMI |
|
| Baseline and 12 weeks |
| A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure | 12 weeks, 52 weeks |
| Proportion of LDL-C < 1.4 mmol/L | One week, 12 weeks |
| Thrombolysis in Myocardial Infarction (TIMI) flow grade | TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset |
| Level of troponin | 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 | At hospital discharge, an average of 10 days after randomization |
| Kaifeng |
| Henan |
| China |
| The People's Hospital of Changyuan | Xinxiang | Henan | China |
| Hopeshine Minsheng Hospital of Xinzheng | Xinzheng | Henan | China |
| The People's Hospital of Xuchang | Xuchang | Henan | China |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | China |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C577155 | evolocumab |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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