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Asthma drug could shield hearts after attack, new trial hopes

NCT ID NCT07320625

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether montelukast, a common asthma drug, can reduce heart damage in people having a heart attack. 512 patients with a specific type of heart attack will receive either montelukast or a placebo daily for 3 months. The goal is to see if the drug prevents the heart from becoming enlarged and weak after blood flow is restored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Montelukast
What this could lead to
If it works, this could point toward a new, low-cost way to prevent heart failure after a heart attack by reducing injury when blood flow is restored.
What could go wrong
This is a phase 3 trial, but montelukast is being repurposed for a new use, and previous studies have been small or in animals. It may not show clear benefit in humans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 512 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

myocardial infarction ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myocardial infarction (MI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Dalian University

    RECRUITING

    Dalian, Liaoning, China

  • Fujian provincial hospital

    RECRUITING

    Fuzhou, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangdong, China

  • Harbin Medical University Second Affiliated Hospital

    RECRUITING

    Ha’erbin, China

  • Hunan Provincial People's Hospital

    RECRUITING

    Hunan, China

  • Liaoning Provincial People's Hospital

    RECRUITING

    Shenyang, China

  • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

    RECRUITING

    Wenzhou, China

  • The First Affiliated Hospital of the University of Science and Technology of China

    RECRUITING

    Hefei, China

  • The Second Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Hunan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Hunan, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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