Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Montelukast Arm
干预措施: Montelukast 10 Mg Oral Tablet (Drug)
Control Arm
干预措施: placebo (Other)
结局指标
主要结局
Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4)
时间窗: 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.
次要结局
未报告次要终点
研究者
engy wahsh
Associate Proffessor
October 6 University