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

NCT06364124 | Recruiting

• 1 other identifier: MR-11-23-035852
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI

Keywords

evolocumab; STEMI; LDL-C

Outcome Measures

Primary Outcomes (1)

• Average percent change from baseline in LDL-C levels to discharge and day 30

  30 days

Secondary Outcomes (3)

• 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

Study Arms (2)

Treatment arm: standard post-treatment for STEMI and Evolocumab

EXPERIMENTAL

The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI

Drug: evolocumab; Procedure: standard post-treatment for STEMI

Control arm: standard post-treatment for STEMI

ACTIVE COMPARATOR

Standard post-treatment for STEMI

Procedure: standard post-treatment for STEMI

Interventions

evolocumab DRUG

Preoperative subcutaneous injection of Evolocumab (420mg)，Atorvastatin 40mg per day

Also known as: repatha

Treatment arm: standard post-treatment for STEMI and Evolocumab

standard post-treatment for STEMI PROCEDURE

standard post-treatment for STEMI

Control arm: standard post-treatment for STEMI; Treatment arm: standard post-treatment for STEMI and Evolocumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Luhe Hospital: lead

Study Sites (1)

Beijing luhe hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

rui yan

CONTACT

17746570262; yanrui4112@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 15, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

CN (1)