Abstract
We conducted a randomized exploratory study to assess safety and the probability of a favorable outcome with adjunctive argatroban, a direct thrombin-inhibitor, administered to recombinant tissue-type plasminogen activator (r-tPA)-treated ischemic stroke patients. Patients treated with standard-dose r-tPA, not receiving endovascular therapy, were randomized to receive no argatroban or argatroban (100 μg/kg bolus) followed by infusion of either 1 (low dose) or 3 μg/kg per minute (high dose) for 48 hours. Safety was incidence of symptomatic intracerebral hemorrhage. Probability of clinical benefit (modified Rankin Scale score 0-1 at 90 days) was estimated using a conservative Bayesian Poisson model (neutral prior probability centered at relative risk, 1.0 and 95% prior intervals, 0.33-3.0). Ninety patients were randomized: 29 to r-tPA alone, 30 to r-tPA+low-dose argatroban, and 31 to r-tPA+high-dose argatroban. Rates of symptomatic intracerebral hemorrhage were similar among control, low-dose, and high-dose arms: 3/29 (10%), 4/30 (13%), and 2/31 (7%), respectively. At 90 days, 6 (21%) r-tPA alone, 9 (30%) low-dose, and 10 (32%) high-dose patients were with modified Rankin Scale score 0 to 1. The relative risks (95% credible inter...Continue Reading
References
Dec 16, 1995·BMJ : British Medical Journal·R J LilfordD Braunholtz
Jan 1, 1997·Seminars in Thrombosis and Hemostasis·Y Tamao, R Kikumoto
Aug 24, 1999·BMJ : British Medical Journal·D J SpiegelhalterK R Abrams
Jan 6, 2000·Lancet·D L DeMetsD G Julian
Sep 26, 2002·Neurology·Andrei V Alexandrov, James C Grotta
Jan 30, 2007·Lancet·Nils WahlgrenUNKNOWN SITS-MOST investigators
Feb 10, 2007·Stroke; a Journal of Cerebral Circulation·Maher SaqqurUNKNOWN CLOTBUST Investigators
Oct 25, 2008·Journal of Clinical Epidemiology·Duminda N WijeysunderaAndreas Laupacis
Oct 29, 2008·Neurology·M LouM Selim
Aug 13, 2011·Journal of Biopharmaceutical Statistics·Pablo BonangelinoChenguang Wang
Jan 10, 2012·Stroke; a Journal of Cerebral Circulation·Andrew D BarretoJames C Grotta
Jun 20, 2012·Statistics in Medicine·J Jack Lee, Caleb T Chu
Sep 6, 2013·Epilepsia·Thomas BleckJaideep Kapur
Jan 30, 2014·Stroke; a Journal of Cerebral Circulation·Patrick LydenPadmesh Rajput
Aug 7, 2014·Stroke; a Journal of Cerebral Circulation·Neal M RaoJeffrey L Saver
Aug 6, 2015·Stroke; a Journal of Cerebral Circulation·Opeolu AdeoyeArthur M Pancioli
Aug 19, 2015·Contemporary Clinical Trials·Mohammad H RahbarAndrew D Barreto
May 12, 2016·Trials·Jon E TysonAbhik Das
Jun 13, 2016·Lancet Neurology·William N WhiteleyUNKNOWN Stroke Thrombolysis Trialists' Collaboration
Aug 11, 2016·Stroke; a Journal of Cerebral Circulation·Kennedy R LeesUNKNOWN Stroke Thrombolysis Trialists’ Collaborators Group
Nov 12, 2016·Stroke; a Journal of Cerebral Circulation·Aravind GaneshUNKNOWN ESCAPE Trial Investigators
Citations
Feb 3, 2018·Annals of Neurology·Patrick D Lyden
Jan 15, 2018·Journal of the American Heart Association·Laurent DerexNorbert Nighoghossian
Jul 30, 2017·Stroke; a Journal of Cerebral Circulation·Andrew D Barreto, James C Grotta
Jul 30, 2017·Stroke; a Journal of Cerebral Circulation·Nirav H Shah
Jan 28, 2018·Stroke; a Journal of Cerebral Circulation·Mun Hee ChoiJi Man Hong
Jan 26, 2018·Stroke; a Journal of Cerebral Circulation·William J PowersUNKNOWN American Heart Association Stroke Council
Jun 5, 2019·Journal of Stroke·Jong S Kim
Jun 27, 2019·Acta Biochimica Et Biophysica Sinica·Jing WangYujun Pan
Feb 6, 2020·Clinical and Applied Thrombosis/hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis·Ling-Shan ZhouHui-Sheng Chen
Sep 30, 2020·Translational Stroke Research·Fenghui YeGuohua Xi
Oct 30, 2018·Journal of the American Heart Association·Matthias EbnerSven Poli
Dec 19, 2018·Medicine·Maria Mirabela ManeaSorin Tuţă
Oct 31, 2019·Stroke; a Journal of Cerebral Circulation·William J PowersDavid L Tirschwell
Feb 7, 2020·Current Treatment Options in Neurology·Mikel S EhntholtMackenzie P Lerario
Sep 14, 2019·Circulation. Cardiovascular Quality and Outcomes·Kristen B SlaughterFarhaan S Vahidy
Oct 31, 2020·Cellular and Molecular Neurobiology·Chengli LiuWei Wang
Dec 11, 2020·International Journal of Stroke : Official Journal of the International Stroke Society·S Iris DeedsOpeolu Adeoye
Sep 26, 2020·Clinical Neurology and Neurosurgery·Shumin ChenHao Sun
Jan 21, 2021·Seminars in Neurology·Adam L GottulaOpeolu Adeoye
Feb 6, 2021·Journal of Neurology, Neurosurgery, and Psychiatry·David J SeiffgeTeddy Y Wu
Sep 3, 2019·World Neurosurgery·Jeeyong KimJae Hoon Sung
Apr 10, 2021·Purinergic Signalling·Gabriel C MüllerDiogo O Souza
Apr 6, 2021·European Stroke Journal·Eivind BergeGuillaume Turc
Apr 27, 2021·JAMA Neurology·Brent StrongMathew J Reeves
May 18, 2021·Journal of Neuro-ophthalmology : the Official Journal of the North American Neuro-Ophthalmology Society·Sean KellyKoto Ishida
May 30, 2021·Neurología : publicación oficial de la Sociedad Española de Neurología·UNKNOWN Grupo de trabajo multidisciplinar de FACME sobre el manejo de la trombosis venosa cerebral relacionada con la vacunación fre
Jun 12, 2021·Neurología·UNKNOWN FACME multidisciplinary working group on the management of cerebral venous sinus thrombosis associated with COVID-19 vaccina
Jul 20, 2021·Journal of Clinical Neuroscience : Official Journal of the Neurosurgical Society of Australasia·Xiaojun HouDan Qi
Aug 25, 2021·BMC Neurology·Lan HuYongjun Cao
Dec 7, 2018·Lancet Neurology·Audrey M ThiebautBenoit D Roussel