beta
Trial Radar AI
Clinical Trial NCT07320625 for Myocardial Infarction (MI) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Efficacy of Montelukast on STEMl Patients Phase 3 512 Preventive Novel Treatment

Recruiting
Clinical Trial NCT07320625 is designed to study Treatment for Myocardial Infarction (MI). It is a Phase 3 interventional study that is recruiting, having started on 1 February 2026, with plans to enroll 512 participants. Led by Shanghai Zhongshan Hospital, it is expected to complete by 1 May 2027. The latest data from ClinicalTrials.gov was last updated on 13 January 2026.
Brief Summary
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 ...Show More
Official Title

Clinical Therapeutic Efficacy of Montelukast on Anterior STEMl Patients With Primary Percutaneous Coronary Intervention

Conditions
Myocardial Infarction (MI)
Other Study IDs
  • KY2025011
NCT ID Number
NCT07320625
Start Date (Actual)
2026-02-01
Last Update Posted
2026-01-13
Completion Date (Estimated)
2027-05-01
Enrollment (Estimated)
512
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
montelukast
myocardial infarction
primary percutaneous coronary intervention
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo Comparatorplacebo group
Placebo
After enrollment, patients received placebo drug at a dose of 10 mg per day for 3 months.
Experimentalmontelukast group
Montelukast
After enrollment, patients received montelukast drug at a dose of 10 mg per day for 3 months.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Left ventricular remodelling post-myocardial infarction
The cardiac magnetic resonance (CMR) is used to assess the cardiac structure and function of all enrolled patients (512) at the time of enrollment and 24 weeks after enrollment, obtaining data on left ventricular end-diastolic volume (LVEDV). If the change in LVEDV exceeds 10% from the time of enrollment to the 24-week follow-up, it will be considered as the occurrence of left ventricular remodelling (LVR).
From enrollment to the end of treatment at 24 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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).
Shanghai Zhongshan Hospital logoShanghai Zhongshan Hospital
Study Responsible Party
Xu Lei, Principal Investigator, Dr, Shanghai Zhongshan Hospital
Study Central Contact
Contact: Aijun Sun, 021-64041990, [email protected]
12 Study Locations in 1 Countries

Liaoning

Affiliated Zhongshan Hospital of Dalian University, Dalian, Liaoning, China
Qin Yu, Contact, 0411-62893000, [email protected]
Qin Yu, Principal Investigator
Recruiting

Shanghai Municipality

Zhongshan Hospital, Fudan University, Shanghai, Shanghai Municipality, 200032, China
Hanchuan Chen, Contact, 18459111985, [email protected]
Aijun Sun, Principal Investigator
Recruiting
The Second Affiliated Hospital of Dalian Medical University, Dalian, China
Xin Zhao, Contact, 0411-84671291, [email protected]
Xin Zhao, Principal Investigator
Recruiting
Fujian provincial hospital, Fuzhou, China
Yansong Guo, Contact, 0591-87557768, [email protected]
Yansong Guo, Principal Investigator
Recruiting
Guangdong Provincial People's Hospital, Guangdong, China
Yong Liu, Contact, 020-83827812, [email protected]
Yong Liu, Principal Investigator
Recruiting
Harbin Medical University Second Affiliated Hospital, Ha’erbin, China
Bo Yu, Contact, 0451-86605612, [email protected]
Bo Yu, Principal Investigator
Recruiting
The First Affiliated Hospital of the University of Science and Technology of China, Hefei, China
Fan Ouyang, Contact, 0551-96512, [email protected]
Fan Ouyang, Principal Investigator
Recruiting
Hunan Provincial People's Hospital, Hunan, China
Hongwei Pan, Contact, 0731-83929900, [email protected]
Hongwei Pan, Principal Investigator
Recruiting
The Second Xiangya Hospital of Central South University, Hunan, China
Shenghua Zhou, Contact, 0731-85295888, [email protected]
Shenghua Zhou, Principal Investigator
Recruiting
Xiangya Hospital of Central South University, Hunan, China
Yongping Bai, Contact, 0731-89753999, [email protected]
Yongping Bai, Principal Investigator
Recruiting
Liaoning Provincial People's Hospital, Shenyang, China
Aijie Hou, Contact, 024-24016001, [email protected]
Aijie Hou, Principal Investigator
Recruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU, Wenzhou, China
Ge Jin, Contact, 0577-88002682, [email protected]
Ge Jin, Principal Investigator
Recruiting