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Not yet recruiting Phase 2 NCT07537868

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

Phase 2 – studying effectiveness and dosage
Conditions: Acute Myocardial Infarction (AMI)

Sponsor: October 6 University

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Overview
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
Who can participate
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
Interventions
Montelukast 10 Mg Oral Tablet
DRUG
placebo
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
30 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
20.04.2026
Completion date
01.10.2027
Registry ID
NCT07537868
Source
clinicaltrials.gov
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