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

NCT07537868 | Not Yet Recruiting Phase 2

• 1 other identifier: MDP.25.09.191
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Acute Myocardial Infarction (AMI)

Outcome Measures

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.

  Baseline, Day 3, and Week 4

Study Arms (2)

Montelukast Arm

ACTIVE COMPARATOR

Drug: Montelukast 10 Mg Oral Tablet

Control Arm

PLACEBO COMPARATOR

Other: placebo

Interventions

placebo OTHER

placebo

Control Arm

Montelukast 10 Mg Oral Tablet DRUG

Montelukast 10 Mg Oral Tablet

Montelukast Arm

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead
• Mansoura University: collaborator

MeSH Terms

Interventions

montelukast; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Abdallah Alshammari, MD

CONTACT

06500556855; Phd.abdulla7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffessor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04