There is evidence that citicoline is the only neuroprotectant able to improve the functional status of the patients after an acute ischemic stroke. Citicoline is a neuroprotectant drug against cerebral ischemia, with positive results, both in experimental and clinical trials, in the treatment of acute stroke and head injuries Also, the safety profile of citicoline is good, and there are no associated problems when the drug is used in this kind to patients The aim of this study is to confirm the efficacy and safety of citicoline in patients with moderate-to-severe acute ischemic stroke in Egypt, according to the characteristics of the medical care in this country
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 will be 0-2 as a cut-off point for a good outcome and 3-6 for a bad outcome. Also, a record of all the side effects will be done. Any kind of adverse effect must be recorded by filling the CIOMS form. Randomization: computer-generated randomization to either group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Ain Shams University
Cairo, Egypt
RECRUITINGpercentage of patients with a good outcome using modified Rankin scale
the investigators will compare the percentage of patients with good outcomes in the citicoline group and control group according to the modified Rankin scale score. the modified Rankin scale (mRS) is a scale used to assess stroke outcomes, it ranges between 0 and 6 and the higher the score the worse the oucome. the investigators defined patients with good outcomes as patients with (mRS) at 3 months of (0-2), and patients with bad outcomes as those with mRS equals (3-6)
Time frame: 3 months
Incidence of Citicoline-Emergent Adverse Events
the incidence of each adverse event related to citicoline will be calculated and recorded in CIOMS form and the investigators will compare the incidence of each side effect in the citicoline group and in the control group.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.