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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing luhe hospital
RECRUITING
Beijing
Contact Information
Primary
rui yan
yanrui4112@163.com
17746570262
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 84
Treatments
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
Sponsors
Leads: Beijing Luhe Hospital

This content was sourced from clinicaltrials.gov