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

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364124
• Other study ID #: MR-11-23-035852
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Beijing Luhe Hospital
• Contact: rui yan
• Phone: 17746570262
• Email: yanrui4112[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Drug:
• evolocumab
Preoperative subcutaneous injection of Evolocumab (420mg),Atorvastatin 40mg per day

Procedure:
• standard post-treatment for STEMI
standard post-treatment for STEMI

Locations

Country	Name	City	State
China	Beijing luhe hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Luhe Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average percent change from baseline in LDL-C levels to discharge and day 30		30 days
Secondary	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
Secondary	Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30		30 days
Secondary	Number of cardiovascular events to day 30		30 days