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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-75
SponsorOctober 6 University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Chronic use of anti-inflammatory drugs

Severe hepatic or renal impairment

Hypersensitivity to Montelukast

Autoimmune or inflammatory diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Montelukast 10 Mg Oral Tablet

    Drug

    Montelukast 10 Mg Oral Tablet

  • placebo

    Other intervention

    placebo

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Montelukast ArmActive comparator 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

October 6 University

Lead sponsor

Mansoura University

Collaborator