Citicoline in Ischemic Stroke, a Randomized Trial

Kafrelsheikh University

Status and phase: Enrolling; Phase 3

Conditions: Ischemic Stroke

Treatments: Drug: Citicoline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06210646

2391988

Details and patient eligibility

About

Along with the current clinical trial, the efficacy and safety of a 1000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to placebo were assessed through MoCA, NIHSS, mRS, and possible adverse effects.

Full description

The investigators conducted a single-blinded, placebo-controlled, randomized controlled trial between December 2023 and December 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 1000 mg citicoline once daily for 12 months, and the placebo arm, consisting of 400 patients who received a placebo 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

800 participants in 2 patient groups, including a placebo group

citicoline arm

Active Comparator group

Description:

The citicoline arm consists of 400 patients who received 1000 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.

Treatment:

Drug: Citicoline

placebo arm

Placebo Comparator group

Description:

The placebo arm consists of 400 patients who received a placebo capsule 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.

Treatment:

Drug: Placebo