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Open Access 01-12-2022 | Stroke | Study protocol

Protocol of End-PSCI trial: a multicenter, randomized controlled trial to evaluate the effects of DL-3-n-butylphthalide on delayed-onset post stroke cognitive impairment

Authors: Ziyu Liu, Wenhui Lu, Ling Gao, Xiaojuan Guo, Jie Liu, Fan Gao, Kang Huo, Jin Wang, Qiumin Qu

Published in: BMC Neurology | Issue 1/2022

Abstract

Background

Delayed-onset post stroke cognitive impairment (PSCI) results from secondary neurodegeneration induced by stroke. Whereas targeted prevention or treatment strategies are still missing due to lack of evidences. This trial aims to evaluate the preventive effects of DL-3-n-butylphthalide (NBP) on delayed-onset PSCI.

Methods

Effects of NBP on Delayed-onset Post Stroke Cognitive Impairment (End-PSCI) is a prospective, parallel-group, open-label, multicenter, randomized controlled trial with blinded outcome assessment. Hospital patients with acute cerebral infarction (within 2 weeks of onset) will be randomized into either standard medical therapy group or standard medical therapy combined NBP treatment group (NBP 200 mg, three times per day for 24 weeks). The primary outcome is the difference of incidence of delayed-onset PSCI between two groups. The secondary outcomes include difference of white matter degeneration, cognitive scores and prevalence of early-onset PSCI between two groups.

Discussion

End-PSCI trial will provide evidences for NBP preventing delayed-onset PSCI. The secondary outcomes will also provide valuable insights into the pathogenesis of delayed-onset PSCI and mechanism of NBP’s actions.

Trial registration

Trialsearch.who.int, ChiCTR2000032555, 2020/5/2, prospectively registered.

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Title: Protocol of End-PSCI trial: a multicenter, randomized controlled trial to evaluate the effects of DL-3-n-butylphthalide on delayed-onset post stroke cognitive impairment
Authors: Ziyu Liu
Wenhui Lu
Ling Gao
Xiaojuan Guo
Jie Liu
Fan Gao
Kang Huo
Jin Wang
Qiumin Qu
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Stroke
Published in: BMC Neurology / Issue 1/2022
Electronic ISSN: 1471-2377
DOI: https://doi.org/10.1186/s12883-022-02957-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Protocol of End-PSCI trial: a multicenter, randomized controlled trial to evaluate the effects of DL-3-n-butylphthalide on delayed-onset post stroke cognitive impairment

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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