Citicoline in Ischemic Stroke

February 16, 2022 updated by: Hossam Shokri, Ain Shams University

Citicoline in Acute Ischemic Stroke

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 88211
        • Recruiting
        • ain shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,…).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Citicoline
the Citicoline group will receive citicoline 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
Drug: Citicoline 500 MG
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.
NO_INTERVENTION: control
the control group will not receive citicoline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of patients with a good outcome using modified Rankin scale
Time Frame: 3 months

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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Citicoline-Emergent Adverse Events
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 22, 2021

Primary Completion (ANTICIPATED)

April 22, 2022

Study Completion (ANTICIPATED)

June 22, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (ACTUAL)

December 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be available upon appropriate request from authors

IPD Sharing Time Frame

upon finishing study

IPD Sharing Access Criteria

upon proper request from the author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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