Evidence map›Paper›PMID 34836908›Full record

ArticleBMJ open2021

Statin and dual antiplatelet therapy for the prevention of early neurological deterioration and recurrent stroke in branch atheromatous disease: a protocol for a prospective single-arm study using a historical control for comparison.

Yen-Chu Huang, Jiann-Der Lee, Hsu-Huei Weng, Leng-Chieh Lin, Yuan-Hsiung Tsai, Jen-Tsung Yang

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04824911 (Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

NCT04824911 phase2completednot on this map

Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease

TypeinterventionalSponsorChang Gung Memorial HospitalRan2021 to 2025Enrolled376ConditionsAcute Stroke, Dual Antiplatelet Therapy, StatinArmsClopidogrel, Aspirin, Atorvastatin, Rosuvastatin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Observational
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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

6 authors at 2 institutions in 1 country.

Yen-Chu HuangDepartment of Neurology, Chang Gung Memorial Hospital Chiayi Branch, Puzi, Taiwan.ORCID 0000-0001-7885-6376
Jiann-Der LeeDepartment of Neurology, Chang Gung Memorial Hospital Chiayi Branch, Puzi, Taiwan.
Hsu-Huei WengDepartment of Diagnostic Radiology, Chang Gung Memorial Hospital Chiayi Branch, Puzi, Taiwan.ORCID 0000-0002-2020-8912
Leng-Chieh LinDepartment of Emergency Medicine, Chang Gung Memorial Hospital Chiayi Branch, Puzi, Taiwan.
Yuan-Hsiung TsaiCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.ORCID 0000-0003-4906-0365
Jen-Tsung YangCollege of Medicine, Chang Gung University, Taoyuan, Taiwan jents716@ms32.hinet.net.
Chang Gung University · TWChiayi Chang Gung Memorial Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBranch atheromatous disease (BAD) contributes to small-vessel occlusion in cases of occlusion or stenosis of large calibre penetrating arteries, and it is associated with a higher possibility of early neurological deterioration (END) and recurrent stroke in acute ischaemic stroke. As the pathology of BAD is due to atherosclerosis, we postulate that early intensive medical treatment with dual antiplatelet therapy (DAPT) and high-intensity statins may prevent END and recurrent stroke in acute small subcortical infarction caused by BAD. METHODS AND ANALYSIS: In this prospective, single-centre, open-label, non-randomised, single-arm study using a historical control, we will compare early DAPT and high-intensity statin treatment with a historical control group of patients with BAD who were treated with single antiplatelet therapy without high-intensity statin treatment. Patients will be eligible for enrolment if they are admitted for acute ischaemic stroke within 24 hours, have a National Institutes of Health Stroke Scale (NIHSS) score of 1-8 and are diagnosed with BAD by MRI. Patients will take aspirin, clopidogrel and high-intensity statins (atorvastatin or rosuvastatin) within 24 hours of stroke onset, followed by aspirin or clopidogrel alone from day 22. The primary endpoint is the percentage of patients who develop END within 7 days of stroke onset (defined as an increase in the NIHSS score ≥2 points) and recurrent stroke within 30 days. The total sample sizes will be 138 for the intervention group and 277 for the control group. A historical control group will be drawn from previous prospective observation studies. ETHICS AND DISSEMINATION: The protocol of this study has been approved by the Institutional Review Board of Chang Gung Memorial Hospital (202001386A3). All participants will have to sign and date an informed consent form. The findings arising from this study will be disseminated in peer-reviewed journals and academic conferences. TRIAL REGISTRATION NUMBER: NCT04824911.

Indexed as

Brain IschemiaHydroxymethylglutaryl-CoA Reductase InhibitorsStrokeCerebral InfarctionClinical Trials as TopicHumansPlatelet Aggregation InhibitorsProspective StudiesTreatment OutcomeHydroxymethylglutaryl-CoA Reductase InhibitorsPlatelet Aggregation Inhibitorsmagnetic resonance imagingneuroradiologystrokestroke medicinevascular medicine

Identifiers

PMID34836908
PMCPMC8628334
OpenAlexW3216335877

What OpenQuestion holds

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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.