Effect of Montelukast on Inflammatory Markers and Cardiac... | NCT07537868

Studies
Effect of Montelukast on Inflammatory Markers and Cardiac Injury in Patients With Acute Myocardial Infarction

NCT07537868

Sponsor

October 6 University

Status

Recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Acute Myocardial Infarction (AMI)

Interventions

Montelukast 10 Mg Oral Tablet
placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2026Actual

Primary Completion Date

May 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Apr 12, 2026

First Submission Date that Met QC Criteria

Apr 12, 2026

First Posted Date

Apr 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 8, 2026Actual

Name	Class
Mansoura University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a randomized controlled clinical trial designed to evaluate the therapeutic effects of Montelukast in patients diagnosed with Acute Myocardial Infarction (AMI). The study aims to investigate whether the administration of Montelukast influences inflammatory markers and the extent of cardiac injury following a heart attack.Participants will be randomly assigned to receive either the active medication or a placebo to provide high-quality evidence regarding the drug's potential cardioprotective and anti-inflammatory properties. The trial is conducted through the Faculty of Pharmacy and Faculty of Medicine at Mansoura University

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast Arm	Active Comparator		Drug: Montelukast 10 Mg Oral Tablet
Control Arm	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast 10 Mg Oral Tablet	Drug	Montelukast 10 Mg Oral Tablet	Montelukast Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, LTB4)	This outcome measures the change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, and LTB4) from baseline to day 3 and week 4 in patients receiving MoThis outcome measures the change in inflammatory biomarkers (IL-6, TNF-α, hs-CRP, Galectin-3, and LTB4) from baseline to day 3 and week 4 in patients receiving Montelukast compared to placebo. ntelukast compared to placebo.	Baseline, Day 3, and Week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 30-75 years Diagnosed with STEMI within 6 hours of symptom onset Undergoing PCI or thrombolysis Eligible for standard ACS therapy signed Informed consent

Exclusion Criteria:

Chronic use of anti-inflammatory drugs
Severe hepatic or renal impairment
Hypersensitivity to Montelukast
Autoimmune or inflammatory diseases
Cardiogenic shock, severe heart failure or structural complications such as papillary muscle rupture
Having received cardiopulmonary resuscitation
Severe and inadequately controlled hypertension
History of myocardial infarction
Concomitant active bleeding or visceral hemorrhage
Concomitant malignant tumors, lymphomas, leukemias, or other diseases
gastrointestinal surgery within the past 4 weeks that may affect the absorption of the investigational drug
Family history of psychiatric disorders
Pregnancy or lactation
Participation in another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abdallah Alshammari, MD	Contact	06500556855		Phd.abdulla7@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura Faculty of Medicine hospital	Recruiting	Al Mansurah			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast
D013607	Tablets

Ancestor Terms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

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Browse Branches

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