Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction

Sponsor
Beijing Luhe Hospital
Study ID
NCT06364124
Status
Unknown

Conditions

  • STEMI

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • evolocumab — DRUG
    Preoperative subcutaneous injection of Evolocumab (420mg)，Atorvastatin 40mg per day
  • standard post-treatment for STEMI — PROCEDURE
    standard post-treatment for STEMI

Study Details

Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.

Key Dates

Start date
Jun 1, 2023
Status verified
May 2024
Primary completion
Jun 1, 2024
Completion
Jun 1, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm: standard post-treatment for STEMI and Evolocumab
    The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI
  • Active Comparator: Control arm: standard post-treatment for STEMI
    Standard post-treatment for STEMI

Primary Outcome Measure

Average percent change from baseline in LDL-C levels to discharge and day 30 [ Time Frame: 30 days ]

Central Contacts

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