RT Journal Article
SR Electronic
T1 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
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 136
OP 141
DO 10.1136/svn-2023-002644
VO 10
IS 1
A1 Jia, Qian
A1 Lei, Peng
A1 Sun, Li
A1 Jia, Wei Li
A1 Pan, Yuesong
A1 Yuan, Baoshi
A1 Wang, Yinkai
A1 Zhou, Qi
A1 Meng, Xia
A1 Jing, Jing
A1 Lin, Jinxi
A1 Wang, Anxin
A1 Zhang, Shuting
A1 Hong, Zhen
A1 Yang, Yu
A1 Xiong, Yunyun
A1 Li, Zixiao
A1 Wang, Yilong
A1 Zhao, Xingquan
A1 Wang, Yongjun
YR 2025
UL http://svn.bmj.com/content/10/1/136.abstract
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.