Montelukast to protect the heart after an anterior STEMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Aijun Sun
• Email: sun.aijun@zs-hospital.sh.cn
• Phone: 021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.