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Recruiting NCT07537868

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

Phase II Interventional Acute Myocardial Infarction (AMI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Montelukast 10 Mg Oral Tablet, placebo.
Who it may be relevant to
Registry conditions: Acute Myocardial Infarction (AMI). Basic parameters: 30 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Drug Montelukast 10 Mg Oral Tablet
    Montelukast 10 Mg Oral Tablet
  • Other placebo
    placebo

Primary outcome measures

  • Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4) [Time frame: Baseline, Day 3, and Week 4]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Egypt · 1 center
  • Mansoura Faculty of Medicine hospital — Al Mansurah

Identifiers

NCT: NCT07537868 · MDP.25.09.191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗