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Recruiting Phase 2 NCT07537868

NCT07537868 Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction

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Clinical Trial Summary
NCT ID NCT07537868
Status Recruiting
Phase Phase 2
Sponsor October 6 University
Condition Acute Myocardial Infarction (AMI)
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2026-04-20
Primary Completion 2027-05

Eligibility & Interventions

Sex All sexes
Min Age 30 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Montelukast 10 Mg Oral Tabletplacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2026-04-20 with a primary completion date of 2027-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

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

Contact & Investigator

Central Contact

Abdallah Alshammari, MD

✉ Phd.abdulla7@gmail.com

📞 06500556855

Frequently Asked Questions

Who can join the NCT07537868 clinical trial?

This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Acute Myocardial Infarction (AMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07537868 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT07537868 currently recruiting?

Yes, NCT07537868 is actively recruiting participants. Contact the research team at Phd.abdulla7@gmail.com for enrollment information.

Where is the NCT07537868 trial being conducted?

This trial is being conducted at Al Mansurah, Egypt.

Who is sponsoring the NCT07537868 clinical trial?

NCT07537868 is sponsored by October 6 University. The trial plans to enroll 80 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology