Evidence map›Paper›PMID 37308251›Full record

ArticleStroke and vascular neurology2024

Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial.

Yu Fu, Renhong Tang, Rong Chen, Anxin Wang, Jinsheng Ren, Shunwei Zhu, Xiaofei Feng, Dongsheng Fan

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Stroke and vascular neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04950920 (Phase III Clinical Trial of Y-2 Sublingual Tablet in the Treatment of Acute Ischemic Stroke - a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04950920 phase3completednot on this map

Phase III Clinical Trial of Y-2 Sublingual Tablet in the Treatment of Acute Ischemic Stroke - a Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial

TypeinterventionalSponsorPeking University Third HospitalRan2021 to 2022Enrolled914ConditionsStrokeArmsY-2 sublingual tablets, d-borneol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yu Fu *Deparment of Neurology, Peking University Third Hospital, Beijing, China.
Renhong Tang *State Key Laboratory of Neurology and Oncology Drug Development, Nanjing, Jiangsu, China.
Rong Chen *Neurodawn Pharmaceutical Co., Ltd, Nanjing, Jiangsu, China.
Anxin WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Jinsheng RenState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, Jiangsu, China.
Shunwei ZhuState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, Jiangsu, China.
Xiaofei FengState Key Laboratory of Neurology and Oncology Drug Development, Nanjing, Jiangsu, China.
Dongsheng FanDeparment of Neurology, Peking University Third Hospital, Beijing, China dsfan@sina.com.ORCID 0000-0002-3129-9821

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeClinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke (AIS). The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with AIS. METHODS AND

designThis is a randomised, double-blind, placebo-controlled, multicentre, parallel-group trial of Y-2 sublingual tablet on patients with AIS.An estimated 914 patients at age of 18-80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 days. Patients are at score 6-20 points on National Institutes of Health Stroke Scale (NIHSS) and had a modified Rankin Scale (mRS) ≤1 before this stroke, except mechanical thrombectomy and neuroprotective agents treatment. STUDY OUTCOMES: The primary outcome is the proportion of patients with mRS ≤1 on day 90 after randomisation. Secondary efficacy outcomes include mRS score on day 90, the proportion of patients with mRS ≤2 on day 90; the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score ≤1 at the days 14, 30 and 90. DISCUSSION: This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS. TRIAL REGISTRATION NUMBER: NCT04950920.

Indexed as

Brain IschemiaIschemic StrokeStrokeAdolescentAdultAgedAged, 80 and overClinical Trials, Phase III as TopicDouble-Blind MethodHumansMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeUnited StatesYoung AdultClinical TrialStroke

Identifiers

PMID37308251
PMCPMC10956111

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.