"The Effect of Trimetazidine on the Clinical Outcome of Acute Ischemic Stroke Patients"

NCT06656442 | Completed Phase 3 DMC

• 1 other identifier: TMZ and AIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators need to test the effect of Trimetazidine on the pro-inflammatory marker Interleukin - 18 , NIHSS score, and mRs score of acute ischemic stroke patients.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stoke; Trimetazidine; metabolic modulator; infarct size; out of window; brain edema; interleukin - 18

Outcome Measures

Primary Outcomes (4)

• Serum level of interleukin -18

  A decrease in the serum level of the pro-inflammatory marker.

  7 days

• National Institutes of Health Stroke Scale

  An improvement in the NIHSS score Minimum: 1 Maximum: 42

  7 days

• The Modified Rankin Score

  An improvement in the mRs score Minimum: 0 Maximum: 6

  90 days

• Adverse Effects

  Any adverse effect that appeared on the patients.

  Till we reach out sample size: 60 patients (assessed within 1 year)

Study Arms (2)

Trimetazidine and Standard of care

ACTIVE COMPARATOR

AIS patients receiving standard of care and Trimetazidine 35mg/12hrs within 12 hours of admission

Drug: Trimetazidine

Standard of care only

NO INTERVENTION

AIS patients receiving standard of care only.

Interventions

Trimetazidine DRUG

an anti-ischemic medication.

Also known as: Vastarel Mr, Metacardia Mr

Trimetazidine and Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old) admitted to the stroke unit with a diagnosis of acute ischemic stroke by CT scan after excluding hemorrhagic stroke
• Patients with an NIHSS score between 5 and 25
• Within 6 - 12 hours from the initial symptoms presentation.

You may not qualify if:

• Thrombolysis-eligible patients
• Patients already on Trimetazidine for any other indication
• Patients who are NPO
• Patients with impaired liver function are defined as INR of 1.5 or higher, elevated AST and ALT more than 3 times the upper normal limit, thrombocytopenia with platelets, 150, 000 in a patient without cirrhosis or preexisting liver disease.
• Patients with inadequate renal function defined as creatinine clearance of 60 mls/min or less
• Pregnancy and lactation
• Contraindications of trimetazidine such as hypersensitivity to TMZ, Parkinson's disease, tremors, restless leg syndrome, or other movement disorders

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Brain Edema

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: The study will be a prospective, randomized controlled, open-label clinical trial conducted on 60 acute ischemic stroke patients

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: September 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

EG (1)