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

Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction: A Single-center，Randomized,Open-label Trial

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI
• Intervention / Treatment: Drug: evolocumab; Procedure: standard post-treatment for STEMI

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: rui yan; Phone Number: 17746570262; Email: yanrui4112@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Luhe hospital
    • Contact: rui yan; Phone Number: 17746570262; Email: yanrui4112@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: evolocumab; Preoperative subcutaneous injection of Evolocumab (420mg)，Atorvastatin 40mg per day; Other Names: repatha; Procedure: standard post-treatment for STEMI; standard post-treatment for STEMI
Active Comparator: Control arm: standard post-treatment for STEMI; Standard post-treatment for STEMI	Procedure: standard post-treatment for STEMI; standard post-treatment for STEMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average percent change from baseline in LDL-C levels to discharge and day 30	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Luhe Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: STEMI; LDL-C; evolocumab
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Protease Inhibitors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Serine Proteinase Inhibitors; PCSK9 Inhibitors; Evolocumab
• Other Study ID Numbers: MR-11-23-035852

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No