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Not Yet Recruiting NCT05613426

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

Conditions: ST Elevation Myocardial Infarction (STEMI)

Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE4
Enrollment: 330
Sponsor: Henan Institute of Cardiovascular Epidemiology

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.

Eligibility Criteria

Inclusion Criteria:Age 18-75 yearsPersistent chest pain or chest discomfortOnset within 12 hoursST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changesPrimary PCI is plannedExclusion Criteria:Contraindications to Statins or PCSK9 inhibitorsPrior intravenous thrombolytic therapyPrior use of Statins, PCSK9 inhibitors or EzetimibeCardiogenic shockAcute heart failure or pulmonary edemaPrior chronic heart failureSevere 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 resuscitationDefinite 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 drugsSevere chronic obstructive pulmonary disease or respiratory failureSevere infectionNeurological disordersBleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last monthActive bleeding or bleeding diathesesUse of anticoagulantsMalignant tumors or other pathophysiological conditions with an expected survival time of less than 1 yearPregnant or lactating women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05613426). StuddyBuddy aggregates publicly available trial information.