NCT07320625

Efficacy of Montelukast on STEMl Patients

Recruiting now Phase 3 Last updated 13 January 2026

What this trial tests

Phase 3 trial testing Montelukast in Myocardial Infarction (MI) in 512 participants. Currently enrolling.

Timeline

1 February 2026

Primary endpoint
1 February 2027

1 May 2027

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	512
Start date	1 February 2026
Primary completion	1 February 2027
Estimated completion	1 May 2027
Sites	12 locations across China

Drugs / interventions tested

• Montelukast (montelukast) — full drug profile →
• Placebo

Conditions studied

• Myocardial Infarction (MI) — all drugs for Myocardial Infarction (MI) →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 75, any sex, with Myocardial Infarction (MI). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute myocardial infarction (AMI) is one of the leading causes of patient mortality worldwide. Each year, over 8 million people globally die from AMI, with approximately 30% of these cases being ST-segment elevation myocardial infarction (STEMI). Despite the continuous development of reperfusion therapy strategies in recent years, which have benefited countless STEMI patients, studies have shown that even when STEMI patients receive primary percutaneous coronary intervention (pPCI) within the therapeutic time window, the in-hospital mortality rate remains as high as 4%, while the one-year post-discharge mortality rate reaches 10%. Among the survivors, about 20% further progress to heart failure.

Myocardial ischemia-reperfusion injury (I/RI) is the primary pathological mechanism underlying the residual risk in STEMI patients following pPCI treatment, directly influencing disease progression and clinical outcomes. Therefore, cardiac protection strategies aimed at targeted improvement of myocardial I/RI to enhance patient prognosis are of paramount importance. In recent research, we have identified and elucidated a novel mechanism by which ALDH2 gene deficiency exacerbates I/RI through the ER stress/Mgst2/LTC4 signaling pathway, mediating the formation of neutrophil extracellular traps (NETosis). Furthermore, we discovered that the use of leukotriene C4 (LTC4) receptor antagonists can effectively block the ER stress/Mgst2/NETosis myocardial injury axis, thereby significantly reducing infarct size and improving cardiac function in I/RI model mice. In clinical cohorts, we observed a significant elevation in LTC4 levels during the acute phase in STEMI patients receiving pPCI. More importantly, elevated LTC4 levels were closely associated with the occurrence of left ventricular adverse remodeling and poor cardiovascular prognosis, suggesting that effective inhibition of the LTC4-related myocardial injury axis during the acute phase of myocardial infarction could yield direct clinical benefits. This highlights the critical role of LTC4 in I/RI and the clinical potential of targeted LTC4 receptor therapy strategies.

Montelukast is a potent leukotriene receptor antagonist with proven preventive and therapeutic effects on asthma, allergic rhinitis, and chronic obstructive pulmonary disease. In recent years, the drug repurposing strategy of montelukast in cardiovascular diseases has garnered increasing attention. Researchers have found that montelukast is closely associated with a reduced risk of major adverse cardiovascular events, indicating its therapeutic potential in cardiovascular diseases. On the other hand, mechanistic studies have also revealed that montelukast can significantly improve infarct size and ventricular remodeling levels in myocardial infarction model mice by blocking leukotriene receptors. A meta-analysis, which combined data from 26 animal experiments and 2 clinical studies, suggested that montelukast holds promising application prospects in reducing the risk of adverse cardiovascular events. Based on these findings, we propose that the drug repurposing strategy of montelukast may represent an effective treatment approach for STEMI patients. We hypothesize that in patients with anterior ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, the application of montelukast can reduce myocardial ischemia-reperfusion injury, thereby improving ventricular remodeling and cardiac function, and exerting cardiac protective effects.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neutrophil extracellular traps in the tumor microenvironment, metastasis, therapy, and beyond: advances, challenges, and perspectives.
   He J, Zhou Z, Cheng G, Li H, et al · · 2026 · PMID 41987275 · DOI 10.1186/s13045-026-01789-4