Effect of Trimetazidine on Acute Ischemic Stroke Outcomes
"The Effect of Trimetazidine on the Clinical Outcome of Acute Ischemic Stroke Patients"
This study is testing if Trimetazidine can improve recovery for adults who have just had an acute ischemic stroke by helping their brain cells use energy better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06656442 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Trimetazidine, a metabolic modulator, on patients suffering from acute ischemic stroke. The study aims to evaluate changes in pro-inflammatory markers, NIHSS scores, and mRs scores in patients treated with Trimetazidine. By shifting cellular metabolism from fatty acid oxidation to glucose oxidation, the drug may help restore energy homeostasis and reduce ischemic damage. The trial includes adult patients diagnosed with acute ischemic stroke within a specific time frame after symptom onset.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with acute ischemic stroke, exhibiting specific NIHSS scores and within the treatment window.
Not a fit: Patients who are thrombolysis-eligible or have contraindications to Trimetazidine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve clinical outcomes and recovery for patients with acute ischemic stroke.
How similar studies have performed: While there have been studies on Trimetazidine's effects in myocardial injury, this specific application in acute ischemic stroke is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Cairo
- Ain Shams University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Asmaa Zakaria, PharmD
- Email: asmaa.tarek.mohamed@pharma.asu.edu.eg
- Phone: 01094455868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.