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Clinical Therapeutic Efficacy of Montelukast on Anterior STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
Led by Shanghai Zhongshan Hospital · Updated on 2026-01-13
512
Participants Needed
12
Research Sites
12 weeks
Total Duration
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AI-Summary
What this Trial Is About
Acute myocardial infarction (AMI), especially ST-segment elevation myocardial infarction (STEMI), remains a leading cause of death worldwide despite advances in reperfusion treatments. Mortality rates remain significant even when primary percutaneous coronary intervention (pPCI) is timely administered, and many survivors develop heart failure. This trial explores the role of leukotriene C4 (LTC4) in myocardial ischemia-reperfusion injury (I/RI) and investigates montelukast, a leukotriene receptor antagonist, as a potential therapy to reduce heart damage and improve outcomes in STEMI patients undergoing pPCI. Participants will be randomly assigned to receive either montelukast at a dose of 10 mg daily or a placebo for three months following enrollment. The study is triple-masked, meaning that participants, care providers, and researchers do not know which treatment is given. The treatment period aims to assess the effects of montelukast on heart protection after the acute myocardial event. Throughout the study, participants will be monitored for changes in left ventricular remodeling over 24 weeks from enrollment to the end of treatment. The trial includes assessments of heart function and structure, with cardiac magnetic resonance imaging used to evaluate outcomes. Safety and tolerance of the treatment will also be observed, and patient progress will be followed up during the 6-month study period to measure cardiac function and remodeling improvements.
CONDITIONS
Brief Title
Efficacy of Montelukast on STEMl Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years and under 75 years
- Diagnosed with acute anterior ST-segment elevation myocardial infarction
- Planned primary percutaneous coronary intervention
- Symptom onset within 12 hours
- Voluntary participation with signed informed consent by patient and family
You will not qualify if you...
- Cardiogenic shock, severe heart failure (Killip Class IV), or structural complications like papillary muscle rupture
- History of cardiopulmonary resuscitation
- Severe uncontrolled hypertension (systolic >180 mmHg or diastolic >110 mmHg)
- Severe liver dysfunction (ALT or AST over three times normal) or renal dysfunction (eGFR <30 mL/min/1.73 m²)
- Previous myocardial infarction
- Active bleeding or visceral hemorrhage
- Malignant tumors, lymphomas, leukemias, or diseases with expected survival under 1 year
- Gastrointestinal surgery in past 4 weeks affecting drug absorption
- Pregnant or breastfeeding women
- Family history of psychiatric disorders
- Participation in another drug study within 4 weeks or use of investigational treatment other than study drug
- Allergy or recent (within 4 weeks) use of montelukast
- Unable to tolerate cardiac magnetic resonance imaging (e.g., metal implants, claustrophobia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive montelukast or placebo daily for 3 months after enrollment.
Visits as needed for medication dispensing and monitoring
Duration - Up to 24 weeks from enrollment
Participants are monitored until 24 weeks from enrollment to assess heart function after treatment.
Approximately 2 to 3 visits post-treatment
Trial Site Locations
Total: 12 locations
1
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Actively Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Actively Recruiting
4
Fujian provincial hospital
Fuzhou, China
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5
Guangdong Provincial People's Hospital
Guangdong, China
Actively Recruiting
6
Harbin Medical University Second Affiliated Hospital
Ha’erbin, China
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7
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, China
Actively Recruiting
8
Hunan Provincial People's Hospital
Hunan, China
Actively Recruiting
9
The Second Xiangya Hospital of Central South University
Hunan, China
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10
Xiangya Hospital of Central South University
Hunan, China
Actively Recruiting
11
Liaoning Provincial People's Hospital
Shenyang, China
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12
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, China
Actively Recruiting
Research Team
A
Aijun Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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