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A prospective, single-center, double-blind, randomized controlled clinical trial of the safety and preliminary efficacy of mepoxizumab for injection in the treatment of patients with ST-segment elevation myocardial infarction

A prospective, single-center, double-blind, randomized controlled clinical trial of the safety and preliminary efficacy of mepoxizumab for injection in the treatment of patients with ST-segment elevation myocardial infarction - To explore the safety and preliminary efficacy of mepocilizumab for injection in the treatment of patients with ST-segment elevation myocardial infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094268
Enrollment
Unknown
Registered
2024-12-19
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

St-segment elevation myocardial infarction

Interventions

Preoperative intravenous infusion of mepocilizumab (0.1mg/kg):Mepolizumab for intravenous infusion (0.1 mg/kg)
Preoperative intravenous infusion of mepocilizumab (0.2mg/kg):Mepolizumab for injection by intravenous infusion (0.2mg/kg)
The same dose of normal saline was administered intravenously before surgery:The same dose of normal saline was administered intravenously

Sponsors

The Second Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 118 years 30 minutes, V2, V3 0.2mV) in two or more adjacent ECG leads or a new onset of left bundle branch block (LBBB3) cardiac biomarker (troponin, CK-MB) increase beyond the 99th percentile of the upper reference limit of the laboratory; (4) the culprit lesion was in situ; (5) Written informed consent was obtained.

Exclusion criteria

Exclusion criteria: (1) known or predicted allergic reaction or history of allergic reaction to any component of the trial treatment; (2) hemodynamic instability; (3) intravenous thrombolysis; (4) the thrombus aspiration catheter could not pass or the diameter of coronary artery stenosis <=70% after thrombus aspiration; (5) left main disease; (6) AMI caused by surgery, trauma, gastrointestinal bleeding or PCI or its complications; (7) AMI occurred in patients who were already hospitalized for other reasons; (8) The researchers judged that the patients had poor compliance and could not complete the study according to the requirements; (9) patients with definite diagnosis of tumors; The life expectancy of patients was <=12 months. (10) patients with heart transplantation; (11) patients who were enrolled in other clinical trials (except other subjects in this project) and did not meet the time limit for the primary end point; (12) patients with cardiac pacemakers, cochlear implants, and implantable electronic devices; The implants should be confirmed as magnetic resonance compatible by the relevant doctors and signed a confirmation certificate, otherwise they were excluded; (13) Patients with aneurysm clips, arterial stent implantation, metal foreign bodies in the brain or eyeball, and orthopedic internal fixation need to be confirmed by relevant doctors to do magnetic resonance examination, otherwise they are excluded; (14) Patients who were pregnant within 3 months, with life-threatening conditions, claustrophobia, and high fever were excluded.

Design outcomes

Primary

MeasureTime frame
Indicators of myocardial infarction assessed by myocardial magnetic resonance at 30 days after surgery;Inflammatory cytokines and chemokines at 30 days after surgery;

Secondary

MeasureTime frame
Major adverse cardiovascular events;Levels of inflammatory cytokines;Myocardial enzyme spectrum;The indexes were examined by echocardiography;

Countries

China

Contacts

Public ContactLi yan

The Second Affiliated Hospital of Air Force Medical University

profleeyan@163.com+86 138 9289 0227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026