Acute ischemic stroke Ictus isquémico agudo
Conditions
Interventions
Product Name: Citicolina
Product Code: Citicolina
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Citicolina
CAS Number: 33818-15-4
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Ferrer Internacional
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 years old. 2. Patients must be treated within 24 hours of their initial stroke symptoms onset. The time between hospital admittance and randomization must be inferior or equal to 3 hours and the time between randomization and the administration of the first dose must be inferior or equal to 1 hour. In the case of inpatients suffering a stroke (in-hospital stroke), the hospital arrival time will be the time of symptoms onset. In the case of unknown time of symptoms onset (i.e. awake stroke), the time of stroke onset will be considered as the last time when the patient was asymptomatic. 3. Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement (independent of the use of rTPA). At the inclusion, patient must have a NIHSS score = 8. 4. Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized. 5. Patients must have an acute ischemic stroke with symptoms, on clinical examination, suggestive of a stroke referable to the middle cerebral artery territory. 6. At inclusion, NIHSS score = 8, with at least 2 of these points from sections 5 & 6 (motor). 7. Immediately (i.e. minutes) pre-stroke, MRS £ 1 (no symptoms at all, or no significant disability despite symptoms; able to carry out all usual duties and activities). [History of past stroke does not, by itself, preclude study entrance]. 8. Women of childbearing potential must have a negative pregnancy test prior to enrolment. 9. 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a). 2. CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage. 3. 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. 4. Previous disorders that may confound the interpretation of the neurological scales. 5. Drug addiction-related disorders. 6. Pre existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous MRS. 7. Pre existing medical condition that, in the Investigator’s opinion, may interfere with the patient's suitability and participation in the study. 8. Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening. 9. Patients under current treatment with citicoline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the effects on recovery at 3 months of oral citicoline 2000 mg/d/6 weeks, after 6 weeks of treatment and 6 weeks of follow-up, in patients with moderate-to-severe acute ischemic strokes (baseline NIHSS higher or equal than 8) in comparison with placebo. Recovery will be evaluated using a primary end-point incorporating 3 components: neurological (National Institute of Health Stroke Scale (NIHSS) less or equal than 1), disability (MRS less or equal than 1), and activities of daily life (Barthel Index higher or equal than 95). These three components will be averaged using GEE. ;Secondary Objective: - Comparison of % of patients with MRS less or equal than 1 at week 12 - Comparison of % of patients with NIHSS less or equal than 1 at week 12 - Comparison of % of patients with Barthel Index higher or equal than 95% at week 12 - Comparison of the distribution of the MRS scores at week 12 - Absolute difference in the NIHSS between baseline and 3 months - The same analyses will be performed at Weeks 1 and 6 - Assessment of citicoline safety and tolerability ;Primary end point(s): The principal parameters include: - MRS - Barthel Index - NIHSS MRS The MRS is a 1-item scale (38) used to assess global degree of disability, with 7 possible responses: 0-6. A score of 0 represents no symptoms at all; a score of 5 represents severe disability. In case of death, the score is 6. This variable will be dichotomized to success (patients with minimal or no disability, defined as having Rankin scores of 0 or 1) or failure (2 to 6). Barthel Index The Barthel Index is a 10 item scale (39) used to assess functions of daily activity level, with 21 possible total scores: 0, 5, 10, ..., 100. A score of 0 means the patient cannot meet the defined criteria and 100 represents the complete independence in activities of daily life. In case of death, the score is 0. This variable will be dichotomized to success (patients with | — |
Countries
Germany, Portugal, Spain
Outcome results
None listed