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โ† Trials
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Efficacy of Montelukast on STEMl Patients

RecruitingPhase 3Ages 18 Years - 75 YearsAllShanghai Zhongshan Hospital
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In plain words

What the trial is, and whether it could suit you

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 progress

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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 mยฒ); 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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What it tests

  • Montelukast
  • Placebo
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Where

12 sites
Affiliated Zhongshan Hospital of Dalian University
Dalian, China
Zhongshan Hospital, Fudan University
Shanghai, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Fujian provincial hospital
Fuzhou, China
Guangdong Provincial People's Hospital
Guangdong, China
Harbin Medical University Second Affiliated Hospital
Haโ€™erbin, China
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, China
Hunan Provincial People's Hospital
Hunan, China

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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