NCT05613426

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

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (EVALUATE-STEMI Trial): a Prospective, Multicenter, Open-label, Adjudicator-blinded, Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST Elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
DRUG	Rosuvastatin 20 mg	Very early use of Rosuvastatin before primary PCI in anterior STEMI
DRUG	Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]	Very early use of Evolocumab before primary PCI in anterior STEMI

Timeline

• Start date: 2023-04-03
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2022-11-14
• Last updated: 2024-12-27

Locations

6 sites across 1 country: China