Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction

May 4, 2026 updated by: engy wahsh, October 6 University

Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial

This is a randomized controlled clinical trial designed to evaluate the therapeutic effects of Montelukast in patients diagnosed with Acute Myocardial Infarction (AMI). The study aims to investigate whether the administration of Montelukast influences inflammatory markers and the extent of cardiac injury following a heart attack.Participants will be randomly assigned to receive either the active medication or a placebo to provide high-quality evidence regarding the drug's potential cardioprotective and anti-inflammatory properties. The trial is conducted through the Faculty of Pharmacy and Faculty of Medicine at Mansoura University

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

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

  • Egypt
      • Al Mansurah, Egypt
        • Recruiting
        • Mansoura Faculty of Medicine hospital
        • Contact:
          • Abdallah

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:

  • Age 30-75 years Diagnosed with STEMI within 6 hours of symptom onset Undergoing PCI or thrombolysis Eligible for standard ACS therapy signed Informed consent

Exclusion Criteria:

  • Chronic use of anti-inflammatory drugs
  • Severe hepatic or renal impairment
  • Hypersensitivity to Montelukast
  • Autoimmune or inflammatory diseases
  • Cardiogenic shock, severe heart failure or structural complications such as papillary muscle rupture
  • Having received cardiopulmonary resuscitation
  • Severe and inadequately controlled hypertension
  • History of myocardial infarction
  • Concomitant active bleeding or visceral hemorrhage
  • Concomitant malignant tumors, lymphomas, leukemias, or other diseases
  • gastrointestinal surgery within the past 4 weeks that may affect the absorption of the investigational drug
  • Family history of psychiatric disorders
  • Pregnancy or lactation
  • Participation in another clinical trial

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Arm
Other: placebo
placebo
Active Comparator: Montelukast Arm
Drug: Montelukast 10 Mg Oral Tablet
Montelukast 10 Mg Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4)
Time Frame: Baseline, Day 3, and Week 4

This outcome measures the change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, and LTB4) from baseline to day 3 and week 4 in patients receiving MoThis outcome measures the change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, and LTB4) from baseline to day 3 and week 4 in patients receiving Montelukast compared to placebo.

ntelukast compared to placebo.
Baseline, Day 3, and Week 4

Collaborators and Investigators

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

Sponsor

October 6 University

Collaborators

Mansoura University

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 (Actual)

April 20, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDP.25.09.191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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