Evidence map›Paper›PMID 31709115›Full record

Trial reportStroke and vascular neurology2019

Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial.

Jie Xu, Yilong Wang, Anxin Wang, Zhiqiang Gao, Xiaoping Gao, Huisheng Chen, Junshan Zhou, Xingquan Zhao, Yongjun Wang

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Stroke and vascular neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 60 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 6 pooled it
3.5field-weighted citation impact, top 7% of its field
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.

NCT01929096 phase2completednot on this map

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial

TypeinterventionalSponsorJiangsu Simcere Pharmaceutical Co., Ltd.Ran2013 to 2015Enrolled400ConditionsAcute Ischemic StrokeArmsCompound Edaravone Injection, Edaravone Injection
NCT06674460 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease: A Randomized, Double-Blind, Placebo-Controlled Study

TypeinterventionalSponsorPeking Union Medical College HospitalRan2025 to 2028Enrolled600ConditionsCerebral Small Vessel Disease, Ischemic StrokeArmsEdaravone Dexborneol Sublingual Tablets, Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 6 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  5. Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Review
  10. Review
  11. Review
  12. Advances in Reperfusion Therapy and Cytoprotection for Acute Ischemic Stroke.Journal of cardiovascular development and disease · 2026
    Review
  13. Article
  14. Article
  15. Cytoprotection Concepts for Ischemic Stroke in the Recanalization Era.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  16. Article
  17. Observational
  18. Current neuropharmacology · 2026
    Article
  19. Review
  20. Article
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

9 authors at 5 institutions in 1 country.

Jie Xu *Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-8320-218X
Yilong Wang *Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Anxin WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4351-2877
Zhiqiang GaoDepartment of Neurology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiaoping GaoDepartment of Neurology, The First Affiliated Hospital of Hunan Normal University, Changsha, China.
Huisheng ChenDepartment of Neurology, General Hospital, PLA Shenyang Military Region, Shenyang, China.ORCID 0000-0002-8490-9435
Junshan ZhouDepartment of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Xingquan ZhaoDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Yongjun WangDepartment of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-9976-2341
Capital Medical University · CNGeneral Hospital of Shenyang Military Region · CNHunan Normal University · CNNanjing Medical University · CNSecond Affiliated Hospital of Nanjing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Edaravone Dexborneol is a novel neuroprotective agent that comprised edaravone and (+)-borneol, a food additive with an anti-inflammatory effect in animal ischaemic stroke models. This study aims to assess the safety and efficacy of Edaravone Dexborneol compared with edaravone in treating patients with acute ischaemic stroke (AIS). Methods: In this multicentre, randomised, double-blind, multiple-dose, active-controlled, phase II clinical trial, patients with AIS within 48 hours after stroke onset were randomly assigned (1:1:1:1) to low-dose (12.5 mg), medium-dose (37.5 mg) or high-dose (62.5 mg) Edaravone Dexborneol groups, and an active control group with edaravone (30 mg) by 30 min intravenous infusion every 12 hours, for 14 consecutive days. The primary efficacy outcome was the proportion of modified Rankin Scale (mRS)score ≤1 at 90 days and National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 14 days after randomisation. The safety outcome included any adverse event during 90 days after treatment. Results: Of 385 patients included in the efficacy analysis, 94 were randomised to low-dose group, 97 to medium-dose group, 98 to high-dose group and 96 to the control group. No significant difference was observed among the four groups on mRS score (mRS ≤1, p=0.4054) at 90 days or NIHSS score change at 14 days (p=0.6799). However, a numerically higher percentage of patients with mRSscore ≤1 at 90 days in the medium-dose (69.39%) and high-dose (65.63%) groups was observed than in the control group (60.64%). No significant difference in severe adverse events was found among the four groups (p=0.3815). Conclusions: Compared with edaravone alone, Edaravone Dexborneol was safe and well tolerated at all doses, although no significant improvement in functional outcomes was observed at 90days. Trial registration number: NCT01929096.

Indexed as

AgedChinaDouble-Blind MethodDrug Administration ScheduleEdaravoneFemaleFunctional StatusHumansInfusions, IntravenousIschemic StrokeMaleMiddle AgedNeuroprotective AgentsRecovery of FunctionTime FactorsTreatment OutcomeEdaravoneNeuroprotective Agentscompound edaravoneedaravoneischemic strokeneuroprotection

Identifiers

PMID31709115
PMCPMC6812637
OpenAlexW2941036014

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.