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RecruitingNCT07537868Updated May 8, 2026

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

A Phase 2 interventional study of Montelukast 10 Mg Oral Tablet and placebo in Acute Myocardial Infarction (AMI), sponsored by October 6 University. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by October 6 University · Phase 2, Interventional, and Other

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Acute Myocardial Infarction (AMI)
03

In context

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Montelukast Arm

    Drug: Montelukast 10 Mg Oral Tablet

  • Placebo comparator
    Control Arm

    Other: placebo

Interventions

  • DrugMontelukast 10 Mg Oral Tablet

    Montelukast 10 Mg Oral Tablet

  • Otherplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4)

    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.

    Time frame: Baseline, Day 3, and Week 4

07

Study locations

1 of 1 sites recruiting
  • Mansoura Faculty of Medicine hospital
    Al Mansurah, Egypt
    • Abdallah · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07537868
Lead sponsor
October 6 University
Collaborators
Mansoura University
Responsible party
engy wahsh (Associate Proffessor, October 6 University) — Principal investigator
First posted
Apr 17, 2026
Start date
Apr 20, 2026
Primary completion
May 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
May 8, 2026

Study contacts

Abdallah Alshammari, MD
Contact
Phd.abdulla7@gmail.com
06500556855

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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