PT  - JOURNAL ARTICLE
AU  - Jia, Qian
AU  - Lei, Peng
AU  - Sun, Li
AU  - Jia, Wei Li
AU  - Pan, Yuesong
AU  - Yuan, Baoshi
AU  - Wang, Yinkai
AU  - Zhou, Qi
AU  - Meng, Xia
AU  - Jing, Jing
AU  - Lin, Jinxi
AU  - Wang, Anxin
AU  - Zhang, Shuting
AU  - Hong, Zhen
AU  - Yang, Yu
AU  - Xiong, Yunyun
AU  - Li, Zixiao
AU  - Wang, Yilong
AU  - Zhao, Xingquan
AU  - Wang, Yongjun
TI  - Efficacy and safety of Ferrous iron on the prevention of Vascular cOgnitive impaiRment among patients with cerebral Infarction/TIA (FAVORITE): rationale and design of a multicentre randomised trial
AID  - 10.1136/svn-2023-002644
DP  - 2025 Feb 01
TA  - Stroke and Vascular Neurology
PG  - 136--141
VI  - 10
IP  - 1
4099  - http://svn.bmj.com/content/10/1/136.short
4100  - http://svn.bmj.com/content/10/1/136.full
SO  - Stroke Vasc Neurol2025 Feb 01; 10
AB  - Background The incidence of vascular cognitive impairment (VCI) is high in patients suffering from ischaemic stroke or transient ischaemic attack (TIA) or with vascular risk factors. Effective prevention strategies for VCI remain limited. Anaemia or low haemoglobin was found as an independent risk factor for adverse outcomes after acute stroke. Anaemia or low haemoglobin was possibly associated with an increased risk of poststroke cognitive impairment. Whether supplement of ferrous iron to correct anaemia reduces the risk of VCI and improves adverse outcomes in patients with ischaemic cerebrovascular disease remains uncertain.Aim We aim to introduce the design and rationale of the safety and efficacy of Ferrous iron on the prevention of Vascular cOgnitive impaiRment in patients with cerebral Infarction or TIA (FAVORITE) trial.Design FAVORITE is a randomised, placebo-controlled, double-blind, multicentre trial that compares supplement of ferrous iron with placebo for recent minor stroke/TIA patients complicated with mild anaemia or iron deficiency: Ferrous succinate sustained-release tablet 0.2 g (corresponding to 70 mg of elemental iron) once daily after or during breakfast for 12 weeks or placebo with much the same colour, smell and size as ferrous iron once daily during or after breakfast for 12 weeks. All paticipants will be followed within the next year.Study outcomes The primary effective outcome is the incidence of VCI at 3 months after randomisation and the primary safety outcome includes any gastrointestinal adverse event during 3 months.Discussion The FAVORITE trial will clarify whether supplement of ferrous iron to correct low haemoglobin reduces the risk of VCI in patients with recent ischaemic stroke or TIA complicated with mild anaemia or iron deficiency compared with placebo.Trial registration number NCT03891277 All data relevant to the study are included in the article or uploaded as online supplemental information.