Montelukast to reduce inflammation and heart damage after a heart attack
Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial
This trial will try montelukast versus placebo to see if it lowers inflammation and limits heart muscle injury in adults aged 30–75 who have a STEMI treated within 6 hours with PCI or thrombolysis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | October 6 University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07537868 on ClinicalTrials.gov |
What this trial studies
This randomized, two-arm, placebo-controlled Phase 2 trial enrolls adults with acute ST-elevation myocardial infarction who present within 6 hours and receive PCI or thrombolysis. Participants are randomly assigned to montelukast 10 mg orally or matching placebo in addition to standard acute coronary syndrome therapy, with blood and clinical data collected. The study measures changes in inflammatory markers and the extent of cardiac injury using biomarkers and clinical/imaging assessments during the acute recovery period. The trial is led by October 6 University in collaboration with Mansoura University and is conducted at Mansoura Faculty of Medicine hospital in Al Mansurah, Egypt.
Who should consider this trial
Good fit: Ideal candidates are adults 30–75 years old with a confirmed STEMI presenting within 6 hours who are undergoing PCI or thrombolysis and can provide informed consent.
Not a fit: Patients with chronic anti-inflammatory use, severe liver or kidney disease, autoimmune or inflammatory disorders, cardiogenic shock or severe heart failure, prior myocardial infarction, active bleeding, recent major GI surgery, pregnancy or lactation, known montelukast hypersensitivity, psychiatric risk, or current participation in another trial are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, montelukast could reduce post-heart-attack inflammation and limit heart muscle damage, potentially improving short- and long-term recovery.
How similar studies have performed: Preclinical data and a few small clinical reports suggest leukotriene blockade may reduce post-MI inflammation, but randomized clinical evidence in acute MI is limited, so this is a relatively novel repurposing approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Al Mansurah
- Mansoura Faculty of Medicine hospital — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Abdallah Alshammari, MD
- Email: Phd.abdulla7@gmail.com
- Phone: 06500556855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.