Citicoline 007
Randomized Efficacy Trial of Citicoline in Patients With Acute Ischemic Stroke
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Status:
Patients enrolled between June, 1996 and June, 1997. Results published 12/99.
Purpose:
To evaluate the safety and effectiveness of 500mg citicoline compared to placebo in patients who are examined within 24 hours of stroke onset.
Interventions:
Citicoline
Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
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Year Started:
1996
Design:
Randomized, double-blind, efficacy trial involving 394 patients at 31 U.S. centers.
Inclusion Criteria
Acute ischemic stroke within 24 hours of onset, clinically assessed to be middle cerebral artery territory, NIH stroke scale >=5, Rankin score <=2, focal neurological deficit lasting >=60 minutes, CT (or MRI) compatible with clinical diagnosis. Must be at least 18 years of age.
Exclusion Criteria
CT/MRI evidence of brain tumor, brain stem or cerebellar infarction, subarachnoid hemorrhage or primary intracerebral hemorrhage; severe coexisting systemic disease limiting life expectancy; history of ventricular dysrhythmias, myocardial infarction, or any severe cardiovascular condition; previous disorder which would impair neurological assessment; improvement in neurological signs and symptoms during baseline assessment; preexisting medical condition that might interfere with participation; surgery needed within 24 hours; recent or planned thrombolytic (rtPA) use.
Patient Involvement:
127 patients received placebo and 267 received citicoline (500 mg po daily) for 6 weeks.
Primary Outcome:
Functional outcome by stratified Barthel Index at 12 weeks.
Secondary Outcome:
(1) Categorized Barthel Index at the other weeks, (2) percentage with full recovery (BI 95 or 100), (3) Modified Rankin scale (4) neurological, behavioral, and cognitive function by use of the NIHSS and Mini-Mental State Examination, (5) mortality, (6) full recovery defined as an NIHSS score of 1, (7) number of days from stroke to hospital discharge, (8) relative rate of improvement for the Barthel Index, Rankin scale, and NIHSS.
Results:
The planned primary analysis failed the proportional odds assumption and was rendered unreliable. There were no between-group differences seen on the planned secondary assessment analyses at 90 days, including the Barthel Index 95 at 12 weeks (last observation carried forward: placebo 40%; citicoline 40%) or mortality rate (placebo 18%; citicoline 17%). However, post hoc analyses in a subgroup of patients with baseline NIHSS 8 found that citicoline-treated patients were more likely to have a full recovery (Barthel 95): placebo 21%; citicoline 33%; P=0.05; whereas no difference was seen in patients with baseline NIHSS<8 (placebo 77%; citicoline 69%; P>0.1.
Source of Information:
Published study results: Stroke 1999;30:2592.
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Web Links and Publications:
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This information last updated on: 9/28/2000
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