Evidence map›Paper›PMID 32664877›Full record

Trial reportBMC neurology2020

Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial.

Jun Ni, Huisheng Chen, Guofang Chen, Yong Ji, Fei Yi, Zhuobo Zhang, Yi Yang, Jin Wu, Xueli Cai, Bei Shao and 14 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 4 pooled it
1.6field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Review
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

24 authors at 20 institutions in 1 country.

Jun NiPeking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
Huisheng ChenGeneral Hospital of Northern Theater Command, Shenyang, China.
Guofang ChenXuzhou Central Hospital, Xuzhou, China.
Yong JiTianjin Huanhu Hospital, Tianjin, China.
Fei YiPingxiang People's Hospital, Pingxiang, China.
Zhuobo ZhangFourth Affiliated Hospital of Harbin Medical University, Harbin, China.
Yi YangFirst Bethune Hospital of Jilin University, Changchun, China.
Jin WuSecond Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xueli CaiLishui Municipal Central Hospital, Lishui, China.
Bei ShaoFirst Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Jianfeng WangDalian Municipal Central Hospital, Dalian, China.
Yafang LiuHuangshi Central Hospital, Huangshi, China.
Deqin GengAffiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Xinhui QuJiangxi Provincial People's Hospital affiliated to Nanchang University, Nanchang, China.
Xiaohong LiJinan Central Hospital, Jinan, China.
Yan WeiHengshui People's Hospital (Harrison International Peace Hospital), Hengshui, China.
Jianping DingXuan Wu Hospital, Capital Medical University, Beijing, China.
Hua LüShaanxi Provincial People's Hospital, Xi'an, China.
Yining HuangPeking University First Hospital, Beijing, China.
Yonghua HuangSeventh Medical Center of the Chinese PLA General Hospital, Beijing, China.
Bo XiaoXiangya Hospital Central South University, Changsha, China.
Tao GongBeijing Hospital, Beijing, China.
Liying CuiPeking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. pumchcuily@sina.com.ORCID http://orcid.org/0000-0001-6342-7835
study collaboration group
Dalian Municipal Central Hospital · CNHarbin Medical University · CNJinan Central Hospital · CNHarrison International Peace Hospital · CNHuangshi Central Hospital · CNShaanxi Provincial People's Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNChinese PLA General Hospital · CNFirst Bethune Hospital of Jilin University · CNPeking University · CNXuzhou Central Hospital · CNBeijing Hospital · CNCentral South University · CNGeneral Hospital of Shenyang Military Region · CNJiangxi Pingxiang People's Hospital · CNLishui Central Hospital · CNNanchang University · CNSecond Affiliated Hospital of Nanjing Medical University · CNTianjin Huanhu Hospital · CNWenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIschemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.

methodsPatients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.

resultsIn total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.

conclusionsThe results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.

trial registrationChinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.

Indexed as

PiperazinesVasodilator AgentsBrain IschemiaChinaDouble-Blind MethodHumansStrokecinepazidePiperazinesVasodilator AgentsAcute cerebral infarctionCerebrovascular diseaseCinepazide maleateStroke

Identifiers

PMID32664877
PMCPMC7359492
OpenAlexW3042900753

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.