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NCT Number: NCT07537868

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

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

Recruiting

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura Faculty of Medicine hospital

Al Mansurah, Egypt

Location status: Recruiting

Location contact

Abdallah

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast 10 Mg Oral Tablet

Drug

Montelukast 10 Mg Oral Tablet

Placebo

Other

placebo

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah Alshammari, MD

CONTACT

[email protected]

06500556855

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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