Status:
COMPLETED
Citicoline in Ischemic Stroke, a Randomized Trial
Lead Sponsor:
Kafrelsheikh University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Along with the current clinical trial, the efficacy and safety of a 2000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to 1000 mg wer...
Detailed Description
The investigators conducted a single-blinded, placebo-controlled, randomized controlled trial between December 2022 and June 2024 after approval of the ethical committee of the faculty of medicine at ...
Eligibility Criteria
Inclusion
- Male \& female patients will be included
- Age more than 18 years.
- Patients must be treated within the first 24 hours of their initial stroke symptoms onset.
- Patients not eligible to receive TPA.
- Patients with a measurable focal neurological deficit (NIHSS score ≥ 4 and less than 21) lasting at least 60 minutes.This deficit must persist from the onset and up to the time of treatment without clinically significant improvement
Exclusion
- Patients eligible for rTPA treatment.
- Patients with any type of aphasia
- Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS.
- CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
- History of ventricular dysrhythmias, acute myocardial infarction within 72 hours before enrolment, unstable angina, decompensated congestive heart failure, or any other acute, severe, uncontrollable, or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study.
- Previous disorders that may confound the interpretation of the neurological scales.
- Drug addiction-related disorders.
- Pre-existing dementia, when dementia implies a disability, measured as a score of 2 or higher in the previous mRS.
- Patients under current treatment with citicoline.
- concomitant administration of other neuroprotectant drugs (such as nimodipine, vinpocetine, piracetam, cerebrolysine).
Key Trial Info
Start Date :
December 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2024
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06210646
Start Date
December 29 2022
End Date
June 29 2024
Last Update
September 19 2024
Active Locations (1)
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1
Kafr Elsheikh University Hospital
Kafr ash Shaykh, Egypt, 33511