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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

evolocumab

Intervention Type DRUG

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

standard post-treatment for STEMI

Intervention Type PROCEDURE

standard post-treatment for STEMI

Control arm: standard post-treatment for STEMI

Standard post-treatment for STEMI

Group Type ACTIVE_COMPARATOR

standard post-treatment for STEMI

Intervention Type PROCEDURE

standard post-treatment for STEMI

Interventions

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evolocumab

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

Intervention Type DRUG

standard post-treatment for STEMI

Intervention Type PROCEDURE

Other Intervention Names

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repatha

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No