Evidence map›Paper›PMID 26202811›Full record

Trial reportCirculation2015

Combination of the Immune Modulator Fingolimod With Alteplase in Acute Ischemic Stroke: A Pilot Trial.

Zilong Zhu, Ying Fu, Decai Tian, Na Sun, Wei Han, Guoqiang Chang, Yinhua Dong, Xiaolin Xu, Qiang Liu, Deren Huang and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2015. 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 155 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 6 pooled it
12.8field-weighted citation impact, top 1% 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.

NCT02002390 phase2completednot on this map

Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

TypeinterventionalSponsorTianjin Medical University General HospitalRan2012 to 2014Enrolled22ConditionsStroke, Vascular Accident, Cerebral Stroke, Ischemic Cerebrovascular AccidentArmsFingolimod
NCT04088630 early_phase1completednot on this mapstarted 2020, after this paper: background citation

Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

TypeinterventionalSponsorWake Forest University Health SciencesRan2020 to 2024Enrolled28ConditionsIntracerebral Hemorrhage, Cerebral Edema, Stroke Hemorrhagic, Intracerebral Hemorrhage, HypertensiveArmsFingolimod, Placebo, Open-label Fingolimod
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 6 syntheses or guidelines pooled it, 273 citations in OpenAlex.

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  20. PA System in the Pathogenesis of Ischemic Stroke.Arteriosclerosis, thrombosis, and vascular biology · 2025
    Review

95 more citing papers are in PubMed but not listed here.

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

11 authors at 3 institutions in 2 countries.

Zilong Zhu *Departments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Ying Fu *Departments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Decai TianDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Na SunDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Wei HanDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Guoqiang ChangDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Yinhua DongDepartment of Neurology, Tianjin Forth Central Hospital, Tianjin, China.
Xiaolin XuDepartment of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, AZ.
Qiang LiuDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Deren HuangNeurology and Neuroscience Associates, Unity Health Network, Akron, OH.
Fu-Dong ShiDepartments of Neurology, Immunology, Radiology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin, China.
Tianjin Huanhu Hospital · CNBarrow Neurological Institute · USSt. Joseph's Hospital and Medical Center · US

Funding

NK cells in CNS inflammation and autoimmunityR01AI083294 · NIAID · ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER · PI SHI, FU-DONG · 2010 to 2014
$2.0M
NIAID NIH HHS R01 AI083294NIAID NIH HHS R01AI083294
6 · The paper itself

Abstract

backgroundInflammatory and immune responses triggered by brain ischemia worsen clinical outcomes of stroke and contribute to hemorrhagic transformation, massive edema, and reperfusion injury associated with intravenous alteplase. We assessed whether a combination of the immune-modulator fingolimod and alteplase is safe and effective in attenuating reperfusion injury in patients with acute ischemic stroke treated within the first 4.5 hours of symptom onset. METHODS AND

resultsIn this multicenter trial, we randomly assigned 25 eligible patients with hemispheric ischemic stroke stemming from anterior or middle cerebral arterial occlusion to receive alteplase alone and 22 patients to receive alteplase plus oral fingolimod 0.5 mg daily for 3 consecutive days within 4.5 hours of the onset of ischemic stroke. Compared with patients who received alteplase alone, patients who received the combination of fingolimod with alteplase exhibited lower circulating lymphocytes, smaller lesion volumes (10.1 versus 34.3 mL; P=0.04), less hemorrhage (1.2 versus 4.4 mL; P=0.01), and attenuated neurological deficits in National Institute of Health Stroke Scales (4 versus 2; P=0.02) at day 1. Furthermore, restrained lesion growth from day 1 to 7 (-2.3 versus 12.1 mL; P<0.01) with a better recovery at day 90 (modified Rankin Scale score 0-1, 73% versus 32%; P<0.01) was evident in patients given fingolimod and alteplase. No serious adverse events were recorded in all patients.

conclusionsIn this pilot study, combination therapy of fingolimod and alteplase was well tolerated, attenuated reperfusion injury, and improved clinical outcomes in patients with acute ischemic stroke. These findings need to be tested in further clinical trials. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02002390.

Indexed as

B-LymphocytesDose-Response Relationship, DrugDrug Therapy, CombinationEdema, CardiacFemaleFibrinolytic AgentsFingolimod HydrochlorideHumansImmunologic FactorsMagnetic Resonance ImagingMaleMiddle AgedMyocardial Reperfusion InjuryPilot ProjectsRecovery of FunctionStrokeFibrinolytic AgentsFingolimod HydrochlorideImmunologic FactorsTissue Plasminogen Activatorbrain ischemiaedemahemorrhageinflammationthrombolytic therapy

Identifiers

PMID26202811
PMCPMC4580515
OpenAlexW1933215500

What OpenQuestion holds

Textmetadata
LicenceTDM
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.