Updated May 2026 · ClinicalTrials.gov
Efficacy of Montelukast on STEMl Patients
Clinical Therapeutic Efficacy of Montelukast on Anterior STEMl Patients With Primary Percutaneous Coronary Intervention
Efficacy of Montelukast on STEMl Patients (NCT07320625) is a Phase 3 interventional studying Myocardial Infarction (MI), sponsored by Shanghai Zhongshan Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.
About This Trial
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.
What Stage of Research Is This?
Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Myocardial Infarction (MI), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.
This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.
A target enrollment of 512 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.
Who May Be Eligible (Plain English)
These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Montelukast
After enrollment, patients received montelukast drug at a dose of 10 mg per day for 3 months.
Placebo
After enrollment, patients received placebo drug at a dose of 10 mg per day for 3 months.
Locations (12)
Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.
How to Talk to Your Doctor About This Trial
Bring the printable summary of this trial — including the NCT ID (NCT07320625), the sponsor (Shanghai Zhongshan Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.
Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.
Authoritative Sources
The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.
Frequently Asked Questions
What is the NCT07320625 clinical trial studying?
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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.
Who can participate in NCT07320625?
Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.
How do I contact the trial site for NCT07320625?
Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.
Is participating in a clinical trial safe?
Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.
Where can I verify the data on this page?
Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.
How This Page Is Built
Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.
Source: ClinicalTrials.gov API v2 record for NCT07320625. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07320625. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-05-08 · Data from ClinicalTrials.gov.