Actively Recruiting
Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial
Led by October 6 University · Updated on 2026-05-08
80
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
O
October 6 University
Lead Sponsor
M
Mansoura University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Montelukast in patients who have experienced Acute Myocardial Infarction (AMI), commonly known as a heart attack. This randomized controlled clinical trial aims to study whether Montelukast can influence inflammatory markers and reduce heart damage after an AMI. The trial is conducted by the Faculty of Pharmacy and Faculty of Medicine at Mansoura University to provide high-quality evidence regarding Montelukast's potential heart-protective and anti-inflammatory effects. Participants will be randomly assigned to one of two groups: one group will receive Montelukast 10 mg oral tablets, while the other will receive a placebo. This triple-blinded study ensures unbiased assessment of the medication's impact. The treatment period and dosing schedules are designed to closely monitor changes in inflammation and heart injury markers. During the study, participants will have blood tests to measure inflammatory biomarkers such as IL-6, TNF-α, hs-CRP, Galectin-3, and LTB4 at the start, on day 3, and at week 4. Researchers will track how these markers change over time to assess the drug's effects. The study will also monitor safety and other health indicators, with participant involvement lasting several weeks to cover the initial and follow-up periods.
CONDITIONS
Brief Title
Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 75 years
- Diagnosed with STEMI within 6 hours of symptom onset
- Undergoing PCI or thrombolysis treatment
- Eligible for standard Acute Coronary Syndrome therapy
- Signed informed consent to participate
You will not qualify if you...
- Chronic use of anti-inflammatory drugs
- Severe liver or kidney impairment
- Known hypersensitivity to Montelukast
- Autoimmune or inflammatory diseases
- Cardiogenic shock, severe heart failure, or structural heart complications
- History of cardiopulmonary resuscitation
- Severe and uncontrolled high blood pressure
- Previous myocardial infarction
- Active bleeding or internal hemorrhage
- Presence of malignant tumors, lymphomas, leukemias, or related diseases
- Gastrointestinal surgery within the last 4 weeks affecting drug absorption
- Family history of psychiatric disorders
- Pregnancy or breastfeeding
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either Montelukast or placebo as part of the study treatment.
Baseline visit, Day 3 visit, and Week 4 visit
Trial Site Locations
Total: 1 location
1
Mansoura Faculty of Medicine hospital
Al Mansurah, Egypt
Actively Recruiting
Research Team
A
Abdallah Alshammari, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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