Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Department of Neuroradiology, All India Institute of Medical Sciences, New Delhi, India.
PLoS One. 2022 May 31;17(5):e0269224. doi: 10.1371/journal.pone.0269224. eCollection 2022.
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.
CAISR was a single centre, randomized, placebo-controlled, parallel-group trial with blinded endpoint assessment. It was approved by the All India Institute of Medical Sciences Institutional ethics committee and registered at the Clinical Trial Registry of India (CTRI/2018/011900). We recruited participants with AIS undergoing recanalization therapy and randomly assigned them to receive either Citicoline or placebo in 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).
The infarct volume decreased from week 1 to week 6 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.
CAISR was the first to evaluate the role of Citicoline, when used immediately after recanalization therapy, when the 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.
急性缺血性脑卒中（AIS）有两种药理学可能性：闭塞动脉再通和缺血损伤的神经保护，后者的疗效存在争议。我们旨在确定 Citicoline 是否在 AIS 再通治疗后立即给药，与单独标准治疗相比，在三个月时是否能改善临床和影像学结局。
CAISR 是一项单中心、随机、安慰剂对照、平行组试验，终点评估设盲。它得到了全印度医学科学研究所机构伦理委员会的批准，并在印度临床试验注册处（CTRI/2018/011900）注册。我们招募了接受再通治疗的 AIS 患者，并将他们随机分配接受 Citicoline 或安慰剂，比例为 1:1。Citicoline 组患者接受静脉注射 Citicoline 1gm，每日 2 次，连续 3 天，随后口服 Citicoline 1gm，每日 2 次，连续 39 天。安慰剂组患者接受静脉注射生理盐水 100ml，连续 3 天，随后口服复合维生素片剂，每日 2 次，连续 39 天。所有患者均接受标准治疗。
盲法评估员在 6 周（MRI 脑梗死体积）和 3 个月（NIHSS 0-2、mRS 0-2 和 Barthel 指数≥95）时进行随访评估。
CAISR 是第一项评估 Citicoline 在再通治疗后立即使用时作用的研究，此时半暗带组织最容易受到保护免受损伤或发生缺血。在主要或次要结局方面，我们未发现 Citicoline 或安慰剂组之间有任何显著差异。
