ST Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
ST Elevation Myocardial Infarction, percutaneous coronary intervention, PCSK9 Inhibitors, left ventricular remodeling
Brief summary
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.
Interventions
Very early use of Rosuvastatin before primary PCI in anterior STEMI
DRUGEvolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
Very early use of Evolocumab before primary PCI in anterior STEMI
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * Persistent chest pain or chest discomfort * Onset within 12 hours * ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes * Primary PCI is planned
Exclusion criteria
* Contraindications to Statins or PCSK9 inhibitors * Prior intravenous thrombolytic therapy * Prior use of Statins, PCSK9 inhibitors or Ezetimibe * Cardiogenic shock * Acute heart failure or pulmonary edema * Prior chronic heart failure * Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis) * Prolonged (\> 20 minutes) cardiopulmonary resuscitation * Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall) * Malignant arrhythmias that are difficult to control with drugs * Severe chronic obstructive pulmonary disease or respiratory failure * Severe infection * Neurological disorders * Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month * Active bleeding or bleeding diatheses * Use of anticoagulants * Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular ejection fraction (LVEF) | Baseline and 12 weeks | Echocardiography Core Laboratory, blinded analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular end diastolic/systolic volume | Baseline and 12 weeks | Echocardiography Core Laboratory, blinded analysis |
| 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 | — |
| Change in left ventricular end diastolic/systolic diameter | Baseline and 12 weeks | Echocardiography Core Laboratory, blinded analysis |
| 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 | — |
| 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 | — |
Countries
China
Contacts
Primary ContactYou Zhang, Doctor
Outcome results
None listed