Citicoline in Ischemic Stroke, a Randomized Trial

NCT06210646 | Completed Phase 3 FDA Drug

• 1 other identifier: 2391988
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke

Keywords

citicoline; ischemic stroke; Egypt

Outcome Measures

Primary Outcomes (2)

• Value of Montreal Cognitive Assessment (MoCA)

  MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Its score ranges from zero to 30 points; the normal value is from 26 to 30; mild cognitive impairment ranges from 18 to 25, Moderate cognitive impairment ranges from 10 to 17, and severe cognitive impairment is below 10 points.

  6 months

• Rate of drug-related complications after 6 months

  All side effects related to the drugs in our study will be reported

  6 months

Secondary Outcomes (4)

• Value of Montreal Cognitive Assessment (MoCA)

  12 months

• Value of Modified Rankin Scale (mRS) at 6 months

  6 months

• Value of Modified Rankin Scale (mRS) at 12 months

  12 months

• Rate of drug-related complications after 12 months

  12 months

Study Arms (2)

citicoline 2000 mg arm

ACTIVE COMPARATOR

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: Citicoline 2000

citicoline 1000 mg arm

ACTIVE COMPARATOR

The placebo arm consists of 400 patients who received citicoline 1000mg 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

Interventions

Citicoline 2000 DRUG

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.

Also known as: group A

citicoline 2000 mg arm

citocoline 1000 DRUG

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.

Also known as: group B

citicoline 1000 mg arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

Location

Related Publications (4)

• Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.

  PMID: 16731270 BACKGROUND

• Adibhatla RM, Hatcher JF. Citicoline mechanisms and clinical efficacy in cerebral ischemia. J Neurosci Res. 2002 Oct 15;70(2):133-9. doi: 10.1002/jnr.10403.

  PMID: 12271462 RESULT

• Cho HJ, Kim YJ. Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4,191 cases. Methods Find Exp Clin Pharmacol. 2009 Apr;31(3):171-6. doi: 10.1358/mf.2009.31.3.1364241.

  PMID: 19536360 RESULT

• Garcia-Cobos R, Frank-Garcia A, Gutierrez-Fernandez M, Diez-Tejedor E. Citicoline, use in cognitive decline: vascular and degenerative. J Neurol Sci. 2010 Dec 15;299(1-2):188-92. doi: 10.1016/j.jns.2010.08.027. Epub 2010 Sep 27.

  PMID: 20875651 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• mohamed G. Zeinhom, MD

  neurology department kafr el-sheikh university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, a specially trained and qualified nurse randomly assigned participants to receive either citicoline or a placebo. We prepared Sequentially numbered opaque sealed envelopes and 800 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 800. Envelopes were attached to the patient\'s files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included citicoline 2000 mg, and Drug B included a citicoline 1000mg. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: We will conduct our randomized controlled trial, which will contain 2 arms: the 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; both groups will receive 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 Record Dates

• First Submitted: January 7, 2024
• First Posted: January 18, 2024
• Study Start: December 29, 2022
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)