Citicoline in Ischemic Stroke

Launched by AIN SHAMS UNIVERSITY · Nov 30, 2021

Keywords

ClinConnect Summary

This is a Prospective Randomized Open-label trial with Blinded Evaluators, Citicoline will be administered in continuous Iv infusion in a dose of 2000 mg per day for the first week following AIS then by oral route for the next 5 weeks.

The number of patients needed for this proposal is 200 (100 per group): group 1 (citicoline): receiving citicoline and group 2 (control) not receiving citicoline. A 10% increase will be expected to avoid possible drop-outs.

Assessment scales:

Eligibility scale: NIHSS score ≥ 8. Outcome scales: modified Rankin Score (mRS) at 3 months Cutoff scores for mRS w...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Both genders aged \> 18 years.
• • Patients must be treated within 24 hours of their initial stroke symptoms onset.
• • Patients not eligible to receive rTPA.
• • Patients with a measurable focal neurological deficit (NIHSS score ≥ 8) lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement
• • Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
• • Patients must have an acute ischemic stroke with symptoms referrable to internal carotid territory.
• • At inclusion, NIHSS score 8-15, with at least 2 of these points from sections 5 \& 6 (motor).
• • Immediately (i.e. minutes) pre-stroke, mRS ≤ 1. \[History of past stroke does not, by itself, preclude study entrance\].
• • Women of childbearing potential must have a negative pregnancy test prior to enrolment.
• • Signed informed consent (following a full explanation of the nature and purpose of this study, the patient or legal guardian(s) or representative(s) must consent to participate by signing the Informed Consent document
• Exclusion Criteria:
• • Patients eligible for rTPA treatment.
• • Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a).
• • CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
• • History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to 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 an score of 2 or higher in the previous mRS.
• • Pre-existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study.
• • Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening.
• • Patients under current treatment with citicoline.
• • Prior (over past 3 months) or concomitant administration of other neuroprotectant drugs (such as nimodipine, vinponcetine, piracetam, cerebrolysin,...).