Group Name

Not applicable

Background And Aims

Two pharmacological possibilities exist for an acute ischemic stroke (AIS): recanalization of the occluded artery and neuroprotection from ischaemic injury, the latter’s efficacy being debatable. We sought to determine whether administration of Citicoline immediately after recanalization therapy for AIS would improve clinical and radiological outcome at three months compared to standard treatment alone.

Methods

CAISR was a single centre, randomized, placebo-controlled, parallel-group trial with blinded endpoint assessment. We recruited participants with AIS undergoing recanalization therapy and randomly assigned them to receive either Citicoline or placebo (1:1 ratio). Citicoline arm patients received Citicoline 1gm BD intravenously for three days, followed by oral Citicoline 1gm BD for 39 days. Placebo arm patients received 100ml intravenous normal saline for three days, followed by multivitamin tablet BD for 39 days. All patients received standard of care.

Blinded assessors did the follow-up assessment at six weeks (MRI Brain-stroke volume) and three months (NIHSS 0-2, mRS 0-2 and Barthel index>=95).

Results

The infarct volume decreased by 2.6 cm³ on placebo versus 4.2 cm³ on Citicoline (p-0.483). The OR for achieving NIHSS 0-2, mRS 0-2 and Barthel index>=95 with Citicoline was found to be 0.96 (95%CI 0.39-2.40), 0.92 (95%CI 0.40-2.05) and 0.87 (95%CI 0.22-2.98) respectively.

Conclusions

CAISR was the first to evaluate the role of Citicoline, when used immediately after recanalization therapy, when penumbral tissue is the most susceptible either to be protected from injury or become ischemic. We did not find any significant difference between the Citicoline or placebo arms with respect to either our primary or secondary outcomes.

Trial Registration Number

Clinical Trial Registry of India (CTRI/2018/011900)