Efficacy of Montelukast on STEMl Patients

January 11, 2026 updated by: Xu Lei, Shanghai Zhongshan Hospital

Clinical Therapeutic Efficacy of Montelukast on Anterior STEMl Patients With Primary Percutaneous Coronary Intervention

Acute myocardial infarction (AMI) is one of the leading causes of patient mortality worldwide. Each year, over 8 million people globally die from AMI, with approximately 30% of these cases being ST-segment elevation myocardial infarction (STEMI). Despite the continuous development of reperfusion therapy strategies in recent years, which have benefited countless STEMI patients, studies have shown that even when STEMI patients receive primary percutaneous coronary intervention (pPCI) within the therapeutic time window, the in-hospital mortality rate remains as high as 4%, while the one-year post-discharge mortality rate reaches 10%. Among the survivors, about 20% further progress to heart failure.

Myocardial ischemia-reperfusion injury (I/RI) is the primary pathological mechanism underlying the residual risk in STEMI patients following pPCI treatment, directly influencing disease progression and clinical outcomes. Therefore, cardiac protection strategies aimed at targeted improvement of myocardial I/RI to enhance patient prognosis are of paramount importance. In recent research, we have identified and elucidated a novel mechanism by which ALDH2 gene deficiency exacerbates I/RI through the ER stress/Mgst2/LTC4 signaling pathway, mediating the formation of neutrophil extracellular traps (NETosis). Furthermore, we discovered that the use of leukotriene C4 (LTC4) receptor antagonists can effectively block the ER stress/Mgst2/NETosis myocardial injury axis, thereby significantly reducing infarct size and improving cardiac function in I/RI model mice. In clinical cohorts, we observed a significant elevation in LTC4 levels during the acute phase in STEMI patients receiving pPCI. More importantly, elevated LTC4 levels were closely associated with the occurrence of left ventricular adverse remodeling and poor cardiovascular prognosis, suggesting that effective inhibition of the LTC4-related myocardial injury axis during the acute phase of myocardial infarction could yield direct clinical benefits. This highlights the critical role of LTC4 in I/RI and the clinical potential of targeted LTC4 receptor therapy strategies.

Montelukast is a potent leukotriene receptor antagonist with proven preventive and therapeutic effects on asthma, allergic rhinitis, and chronic obstructive pulmonary disease. In recent years, the drug repurposing strategy of montelukast in cardiovascular diseases has garnered increasing attention. Researchers have found that montelukast is closely associated with a reduced risk of major adverse cardiovascular events, indicating its therapeutic potential in cardiovascular diseases. On the other hand, mechanistic studies have also revealed that montelukast can significantly improve infarct size and ventricular remodeling levels in myocardial infarction model mice by blocking leukotriene receptors. A meta-analysis, which combined data from 26 animal experiments and 2 clinical studies, suggested that montelukast holds promising application prospects in reducing the risk of adverse cardiovascular events. Based on these findings, we propose that the drug repurposing strategy of montelukast may represent an effective treatment approach for STEMI patients. We hypothesize that in patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, the application of montelukast can reduce myocardial ischemia-reperfusion injury, thereby improving ventricular remodeling and cardiac function, and exerting cardiac protective effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

512

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Dalian, China
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Xin Zhao
      • Fuzhou, China
        • Recruiting
        • Fujian Provincial Hospital
        • Principal Investigator:
          • Yansong Guo
        • Contact:
      • Guangdong, China
        • Recruiting
        • Guangdong provincial people's hospital
        • Principal Investigator:
          • Yong Liu
        • Contact:
      • Ha’erbin, China
        • Recruiting
        • Harbin Medical University Second Affiliated Hospital
        • Principal Investigator:
          • Bo Yu
        • Contact:
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of the University of Science and Technology of China
        • Principal Investigator:
          • Fan Ouyang
        • Contact:
      • Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Principal Investigator:
          • Hongwei Pan
        • Contact:
      • Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Shenghua Zhou
      • Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Principal Investigator:
          • Yongping Bai
        • Contact:
      • Shenyang, China
        • Recruiting
        • Liaoning Provincial People's Hospital
        • Principal Investigator:
          • Aijie Hou
        • Contact:
      • Wenzhou, China
        • Recruiting
        • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
        • Contact:
        • Principal Investigator:
          • Ge Jin
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
        • Principal Investigator:
          • Qin Yu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Aijun Sun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18 years and < 75 years;
  2. Diagnosed with acute anterior ST-segment elevation myocardial infarction and planned to undergo primary percutaneous coronary intervention;
  3. Time from symptom onset ≤ 12 hours;
  4. The patient and their family members voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

  1. Cardiogenic shock, severe heart failure (Killip Class IV), or structural complications such as papillary muscle rupture;
  2. Having received cardiopulmonary resuscitation ;
  3. Severe and inadequately controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg);
  4. Severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding three times the upper limit of normal) or renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²);
  5. History of myocardial infarction;
  6. Concomitant active bleeding or visceral hemorrhage;
  7. Concomitant malignant tumors, lymphomas, leukemias, or other diseases with an expected survival time of less than 1 year;
  8. Having undergone gastrointestinal surgery within the past 4 weeks that may affect the absorption of the investigational drug;
  9. Pregnant or breastfeeding women;
  10. Family history of psychiatric disorders;
  11. Having been enrolled in another drug study within the past 4 weeks or currently receiving any investigational treatment other than the study drug;
  12. Allergic to montelukast or having used montelukast within the past 4 weeks;
  13. Unable to tolerate cardiac magnetic resonance imaging (e.g., patients with magnetic materials in the body or those with claustrophobia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Drug: Placebo
After enrollment, patients received placebo drug at a dose of 10 mg per day for 3 months.
Experimental: montelukast group
Drug: Montelukast
After enrollment, patients received montelukast drug at a dose of 10 mg per day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular remodelling post-myocardial infarction
Time Frame: From enrollment to the end of treatment at 24 weeks
The cardiac magnetic resonance (CMR) is used to assess the cardiac structure and function of all enrolled patients (512) at the time of enrollment and 24 weeks after enrollment, obtaining data on left ventricular end-diastolic volume (LVEDV). If the change in LVEDV exceeds 10% from the time of enrollment to the 24-week follow-up, it will be considered as the occurrence of left ventricular remodelling (LVR).
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD collected throughout the trial

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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