Evidence map›Paper›PMID 22223235›Full record

ArticleStroke2012

The argatroban and tissue-type plasminogen activator stroke study: final results of a pilot safety study.

Andrew D Barreto, Andrei V Alexandrov, Pat Lyden, Jessica Lee, Sheryl Martin-Schild, Loren Shen, Tzu-Ching Wu, April Sisson, Renganayaki Pandurengan, Zhongxue Chen and 11 more

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Stroke, 2012. 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 58 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 3 pooled it
7.6field-weighted citation impact, top 2% 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.

NCT00268762 phase1 / phase2completednot on this map

A Pilot Study To Determine The Safety Of Argatroban Injection In Combination With Tissue Plasmingen Activator (TPA) In Patients With Acute Ischemic Stroke

TypeinterventionalSponsorThe University of Texas Health Science Center, HoustonRan2003 to 2010Enrolled65ConditionsIschemic StrokeArmsargatroban
NCT01464788 phase2terminatednot on this map

ARTSS-2: A Pilot, Phase 2b, Randomized, Multi-center Trial of Argatroban in Combination With Recombinant Tissue Plasminogen Activator for Acute Stroke

TypeinterventionalSponsorAndrew D. Barreto, MDRan2011 to 2015Enrolled90ConditionsIschemic StrokeArmsLow Dose Argatroban, High Dose Argatroban, rt-PA (alteplase)
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Guideline
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  5. Argatroban plus alteplase in posterior versus anterior circulation stroke.Annals of clinical and translational neurology · 2025
    Trial
  6. Trial
  7. Baseline neurological deficit and argatroban plus alteplase in acute ischemic stroke: A post hoc analysis of ARAIS trial.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024
    Trial
  8. Argatroban Increased the Basal Vein Drainage and Improved Outcomes in Acute Paraventricular Ischemic Stroke Patients.Medical science monitor : international medical journal of experimental and clinical research · 2020
    Trial
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  11. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 1 institution in 1 country.

Andrew D BarretoDepartment of Neurology, University of Texas–Houston Medical School, Houston, TX, USA. andrew.d.barreto@uth.tmc.edu
Andrei V Alexandrov
Pat Lyden
Jessica Lee
Sheryl Martin-Schild
Loren Shen
Tzu-Ching Wu
April Sisson
Renganayaki Pandurengan
Zhongxue Chen
Mohammad H Rahbar
Clotilde Balucani
Kristian Barlinn
Rebecca M Sugg
Zsolt Garami
Georgios Tsivgoulis
Nicole R Gonzales
Sean I Savitz
Robert Mikulik
Andrew M Demchuk
James C Grotta
St Ann’s Hospital · GB

Funding

U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
University of Texas Specialized Program in Acute StrokeP50NS044227 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI RAHBAR, MOHAMMAD HOSSEIN · 2002 to 2012
$17.9M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
CTSA: K12 COMPONENTKL2RR024149 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2011
$6.7M
THE UNIVERSITY OF TEXAS HOUSTON STROKE TRAINING PROGRAMT32NS007412 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI SAVITZ, SEAN I · 1998 to 2023
$4.6M
Center for Clinical and Translational Sciences (CCTS)KL2TR000370 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$4.3M
Center for Clinical and Translational SciencesTL1RR024147 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2011
$2.3M
ULTRASOUND ENHANCED THROMBOLYSIS FOR ISCHEMIC STROKEK23NS002229 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI ALEXANDROV, ANDREI V · 2001 to 2004
$617k
NCATS NIH HHS KL2 TR000370NCATS NIH HHS UL1 TR000371NCRR NIH HHS KL2 RR024149NCRR NIH HHS TL1 RR024147NCRR NIH HHS UL1 RR024148NINDS NIH HHS 1K23NS02229-01NINDS NIH HHS 1P50NS044227NINDS NIH HHS K23 NS002229NINDS NIH HHS P50 NS044227NINDS NIH HHS P50NS044227NINDS NIH HHS T32 NS007412NINDS NIH HHS T32NS07412
6 · The paper itself

Abstract

background and purposeArgatroban is a direct thrombin inhibitor that safely augments recanalization achieved by tissue-type plasminogen activator (tPA) in animal stroke models. The Argatroban tPA Stroke Study was an open-label, pilot safety study of tPA plus Argatroban in patients with ischemic stroke due to proximal intracranial occlusion.

methodsDuring standard-dose intravenous tPA, a 100-μg/kg bolus of Argatroban and infusion for 48 hours was adjusted to a target partial thromboplastin time of 1.75× baseline. The primary outcome was incidence of significant intracerebral hemorrhage defined as either symptomatic intracerebral hemorrhage or Parenchymal Hematoma Type 2. Recanalization was measured at 2 and 24 hours by transcranial Doppler or CT angiography.

resultsSixty-five patients were enrolled (45% men, mean age 63±14 years, median National Institutes of Health Stroke Scale=13). The median (interquartile range) time tPA to Argatroban bolus was 51 (38-60) minutes. Target anticoagulation was reached at a median (interquartile range) of 3 (2-7) hours. Significant intracerebral hemorrhage occurred in 4 patients (6.2%; 95% CI, 1.7-15.0). Of these, 3 were symptomatic (4.6%; 95% CI, 0.9-12.9). Seven patients (10%) died in the first 7 days. Within the 2-hour monitoring period, transcranial Doppler recanalization (n=47) occurred in 29 (61%) patients: complete in 19 (40%) and partial in another 10 (21%).

conclusionsThe combination of Argatroban and intravenous tPA is potentially safe in patients with moderate neurological deficits due to proximal intracranial arterial occlusions and may produce more complete recanalization than tPA alone. Continued evaluation of this treatment combination is warranted. CLINICAL

trial registrationURL: www.clinicaltrials.gov. Unique identifier: NCT00268762.

Indexed as

AgedAnticoagulantsAntithrombinsArginineBrain IschemiaCerebral ArteriesCerebral HemorrhageCerebral VeinsDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPartial Thromboplastin TimePilot ProjectsPipecolic AcidsAnticoagulantsAntithrombinsargatrobanArgininePipecolic AcidsSulfonamidesTissue Plasminogen Activator

Identifiers

PMID22223235
PMCPMC3289043
OpenAlexW1975688998

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.