Clinical trial NCT06364124: Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: STEMI
Keywords: evolocumab
STEMI
LDL-C
Lead sponsor: Beijing Luhe Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average percent change from baseline in LDL-C levels to discharge and day 30
timeFrame: 30 days
Secondary outcomes:
measure: Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30
timeFrame: 30 days
measure: Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30
timeFrame: 30 days
measure: Number of cardiovascular events to day 30
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing luhe hospital
Study officials:
References: