Evidence map›Paper›PMID 28989802›Full record

Trial reportStroke and vascular neurology2017

Clopidogrel loading dose versus maintenance dose to treat patients with acute ischaemic stroke in China (CLASS-China): results from a prospective double-blind randomised clinical trial.

Ying Zhao, Wanyong Yang, Zefeng Tan, Wenmin Wang, Weimin Xiao, Jinsheng Zeng, Anding Xu

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Stroke and vascular neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.1field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Oral antiplatelet therapy for acute ischaemic stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Trial
  4. 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

7 authors at 4 institutions in 1 country.

Ying ZhaoDepartment of Neurology and Stroke Center, The First Affiliated Hospital, Jinan University, Guangzhou, China.
Wanyong YangDepartment of Neurology and Stroke Center, The First Affiliated Hospital, Jinan University, Guangzhou, China.
Zefeng TanDepartment of Neurology and Stroke Center, The First Affiliated Hospital, Jinan University, Guangzhou, China.
Wenmin WangDepartment of Neurology, The First Affiliated Hospital, Kunming Medical College, Kunming, Yunnan, China.
Weimin XiaoDepartment of Neurology, Dongguan People Hospital, Dongguan, Guangdong, China.
Jinsheng ZengDepartment of Neurology and Stroke Center, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China.
Anding XuDepartment of Neurology and Stroke Center, The First Affiliated Hospital, Jinan University, Guangzhou, China.
First Affiliated Hospital of Jinan University · CNDongguan People’s Hospital · CNKunming Medical University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe role of clopidogrel in treating patients with acute ischaemic stroke is unclear. We have conducted the clinical trial in order to evaluate the efficacy and safety of clopidogrel with a loading dose in treating patients with non-cardiogenic acute ischaemic stroke.

methodClopidogrel loading dose versus maintenance dose to treat patients with acute ischaemic stroke in China (CLASS-China) was a prospective, randomised, double-blind and placebo-controlled clinical trial in China. Patients with acute ischaemic stroke of non-cardiogenic origin within 48 hours of onset were enrolled and those received thrombolysis were excluded. Enrolled patients were divided into two treatment groups: loading dose and routine dose. The primary outcome was the incidence of stroke recurrence or progression within 7 days. Primary safety outcome was measured by life-threatening haemorrhage. An intent-to-treat analysis was used for the statistical analysis.

resultsFrom March 2008 to March 2010, a total of 303 patients from 16 centres were recruited into this study; six were excluded because of lack of basic information. Since the enrolment was slow and the study drug expired in March 2010, this clinical trial was stopped earlier than planned. No significant baseline and demographic differences were seen between the two groups. There was no difference in primary outcome between the loading dosage group 16.1% (24/149) and control group 14.9% (22/148), respectively (p=0.782). The mortality and disability rate within 90 days in loading dose group (19.6%) was slightly lower than that in controlled group (23.4%), p=0.444. Loading dose group had two (1.3%) cases of fatal haemorrhage and control group had four (2.7%) within 90 days, p=0.674. No significant difference was detected in other adverse events between the groups.

conclusionIn our study stopped early due to slow enrolment, loading dose of clopidogrel does not reduce the risk of recurrent stroke. Future trials with sufficient number of patients enrolled are needed to re-examine this hypothesis.

Indexed as

Secondary PreventionAgedChinaClopidogrelDisease ProgressionDouble-Blind MethodEarly Termination of Clinical TrialsFemaleHumansIntracranial HemorrhagesIschemic StrokeMaleMiddle AgedPatient SelectionPlatelet Aggregation InhibitorsProspective StudiesClopidogrelPlatelet Aggregation InhibitorsAcute ischaemic strokeclopidogrelloading dosenon-cardiogenic stroke

Identifiers

PMID28989802
PMCPMC5628375
OpenAlexW2696116946

What OpenQuestion holds

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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.