Efficacy of Montelukast on STEMl Patients

Plain-language summary

This study compares the medicine montelukast with placebo in patients who have had an ST-segment elevation myocardial infarction (STEMI), a type of heart attack. It is open to patients aged 18 to 75 with acute anterior STEMI who are scheduled for primary percutaneous coronary intervention and are within 12 hours of symptom onset. It is being carried out in Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Shanghai Zhongshan Hospital

Intervention

Montelukast, Placebo

Start date

2/1/2026

Estimated completion

5/1/2027

Countries

China

Related genes

Locations

• Dalian, China
• Shanghai, China
• Dalian, China
• Fuzhou, China
• Guangdong, China
• Ha’erbin, China
• Hefei, China
• Hunan, China
• Hunan, China
• Hunan, China
• Shenyang, China
• Wenzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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).