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)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 3, 2023

Status verified

May 2026

Primary completion

Jul 16, 2025

Completion

May 16, 2026

Study Design

Enrollment

119 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Intensive statin group
  Rosuvastatin, 20 mg per day after randomization
• Experimental: Combined intensive statin and PCSK9 inhibitor group
  Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization
• Experimental: PCSK9 inhibitor alone group
  Evolocumab, 140 mg twice a month after randomization

Primary Outcome Measure

Change in left ventricular ejection fraction (LVEF) [ Time Frame: Baseline and 12 weeks ]