NCT06210646

Citicoline in Ischemic Stroke, a Randomized Trial

Citicoline in Ischemic Stroke, a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 were assessed through MoCA, NIHSS, mRS, and possible adverse effects.

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 Kafr el-Sheik University. The investigators got written informed consent from all eligible patients or their first order of kin before randomization. The study will comprise 2 arms citicoline arm, which consists of 400 patients who received 2000 mg citicoline once daily for 12 months, and the placebo arm, consisting of 400 patients who received 1000 mg citicoline once daily for 12 months; all the patients in the two groups received open-label double antiplatelet in the form of 75 mg aspirin. And 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial. Study Procedures: Every patient in our study will undergo: Clinical workup: History, clinical assessment \& NIHSS, and the Modified Rankin Scale and MoCA scale were recorded at baseline and then after 3 months, 6 months, and 12 months as a follow-up Detection of Risk Factors \& Profiles: Echocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients. 4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients. Imaging Follow UP Non-contrast CT brain on admission and MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels). CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT. Primary End Point: The primary efficacy outcome was the MoCA score after 6 months; the primary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire after 6 months. • Secondary End Point: the secondary efficacy outcomes were: the MoCA after 12 months, mRS after 6 months, and mRS after 12 months, and the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire after 12 months.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Citicoline 2000	The citicoline arm consists of 400 patients who received 2000 mg citicoline once daily for 12 months, and an open-label double antiplatelet in the form of 75 mg aspirin, and 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.
DRUG	citocoline 1000	The placebo arm consists of 400 patients who received a citicoline 1000 mg once daily for 12 months, an open-label double antiplatelet in the form of 75 mg aspirin, and 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.

Timeline

• Start date: 2022-12-29
• Primary completion: 2024-06-29
• Completion: 2024-06-29
• First posted: 2024-01-18
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study