Montelukast to protect the heart after an anterior STEMI

Clinical Therapeutic Efficacy of Montelukast on Anterior STEMl Patients With Primary Percutaneous Coronary Intervention

This trial will test whether giving montelukast around the time of primary PCI can reduce heart damage and later heart failure in adults with anterior STEMI.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 12 sites (Dalian, Liaoning and 11 other locations)
• Trial ID: NCT07320625 on ClinicalTrials.gov

What this trial studies

This phase 3, randomized interventional trial compares montelukast with placebo in adults presenting with acute anterior ST‑segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention within 12 hours of symptom onset. Participants eligible by age and clinical criteria are randomized to receive montelukast or placebo and are followed for in‑hospital outcomes and longer‑term events including mortality and progression to heart failure. The trial targets ischemia‑reperfusion injury as a mechanism for residual risk after reperfusion and aims to test whether leukotriene receptor blockade provides cardiac protection. Enrollment occurs at several tertiary hospitals in China with standardized PCI care and safety monitoring.

Who should consider this trial

Good fit: Adults aged 18–74 with acute anterior STEMI who can receive primary PCI within 12 hours of symptom onset and who can provide informed consent are the intended participants.

Not a fit: Patients with cardiogenic shock or severe heart failure, recent CPR, prior myocardial infarction, severe uncontrolled hypertension, major liver or kidney dysfunction, or active major bleeding are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, montelukast could reduce heart muscle damage from ischemia‑reperfusion and lower short‑term deaths and the chance of developing heart failure after STEMI.

How similar studies have performed: Preclinical data and small clinical or pilot studies have suggested leukotriene blockade might limit reperfusion injury, but large randomized phase 3 evidence for montelukast in STEMI is currently lacking.

Eligibility criteria

Inclusion Criteria:

1. Age \> 18 years and \< 75 years;
2. Diagnosed with acute anterior ST-segment elevation myocardial infarction and planned to undergo primary percutaneous coronary intervention;
3. Time from symptom onset ≤ 12 hours;
4. The patient and their family members voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Cardiogenic shock, severe heart failure (Killip Class IV), or structural complications such as papillary muscle rupture;
2. Having received cardiopulmonary resuscitation ;
3. Severe and inadequately controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg);
4. Severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding three times the upper limit of normal) or renal dysfunction (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²);
5. History of myocardial infarction;
6. Concomitant active bleeding or visceral hemorrhage;
7. Concomitant malignant tumors, lymphomas, leukemias, or other diseases with an expected survival time of less than 1 year;
8. Having undergone gastrointestinal surgery within the past 4 weeks that may affect the absorption of the investigational drug;
9. Pregnant or breastfeeding women;
10. Family history of psychiatric disorders;
11. Having been enrolled in another drug study within the past 4 weeks or currently receiving any investigational treatment other than the study drug;
12. Allergic to montelukast or having used montelukast within the past 4 weeks;
13. Unable to tolerate cardiac magnetic resonance imaging (e.g., patients with magnetic materials in the body or those with claustrophobia).

Where this trial is running

Dalian, Liaoning and 11 other locations

• Affiliated Zhongshan Hospital of Dalian University — Dalian, Liaoning, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, China (Recruiting)
• Fujian provincial hospital — Fuzhou, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangdong, China (Recruiting)
• Harbin Medical University Second Affiliated Hospital — Ha’erbin, China (Recruiting)
• The First Affiliated Hospital of the University of Science and Technology of China — Hefei, China (Recruiting)
• Hunan Provincial People's Hospital — Hunan, China (Recruiting)
• The Second Xiangya Hospital of Central South University — Hunan, China (Recruiting)
• Xiangya Hospital of Central South University — Hunan, China (Recruiting)
• Liaoning Provincial People's Hospital — Shenyang, China (Recruiting)
• The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou, China (Recruiting)

Study contacts

• Study coordinator: Aijun Sun

Conditions Myocardial Infarction; montelukast; myocardial infarction; primary percutaneous coronary intervention