Acute Myocardial Infarction (AMI)
Conditions
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
Interventions
Montelukast 10 Mg Oral Tablet
OTHERplacebo
placebo
Sponsors
October 6 University
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4) | Baseline, Day 3, and Week 4 | 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. |
Countries
Egypt
Contacts
CONTACTAbdallah Alshammari, MD
Outcome results
None listed