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

Not Applicable

Recruiting

• Conditions: STEMI
• Interventions: Drug: evolocumab; Procedure: standard post-treatment for STEMI

• Registration Number: NCT06364124
• Lead Sponsor: Beijing Luhe Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.

• STEMI patients must meet the following criteria:

  1. Chest pain duration ≥ 30 minutes, with ST-segment elevation ≥ 0.1 mV in adjacent two leads on the electrocardiogram.
  2. Onset within 24 hours.
  3. Aged between 18 and 80 years.
  4. Signed informed consent form.

Exclusion Criteria

• Hemodynamically unstable or Killip grade ≥ 2.
• Severe renal insufficiency: Glomerular filtration rate < 30 ml/min/1.73m^2.
• Active liver disease or liver dysfunction: AST or ALT levels > 3 times the upper limit of normal.
• Known allergy to any drug used in the study.
• Previous or planned use of PCSK9 inhibitors.
• Suspected stress cardiomyopathy or acute pericarditis.
• Malignant tumors requiring treatment or other severe systemic diseases.
• Pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm: standard post-treatment for STEMI and Evolocumab	standard post-treatment for STEMI	The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI
Control arm: standard post-treatment for STEMI	standard post-treatment for STEMI	Standard post-treatment for STEMI
Treatment arm: standard post-treatment for STEMI and Evolocumab	evolocumab	The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI

Primary Outcome Measures

Name	Time	Method
Average percent change from baseline in LDL-C levels to discharge and day 30	30 days

Secondary Outcome Measures

Name	Time	Method
Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30	30 days
Number of cardiovascular events to day 30	30 days
Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30	30 days

Trial Locations

Locations (1)

Beijing luhe hospital; 🇨🇳 Beijing, China