| The argatroban and tissue-type plasminogen activator stroke study: final results of a pilot safety study. | |
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MedLine Citation:
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PMID: 22223235 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND PURPOSE: Argatroban 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. METHODS: During 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. RESULTS: Sixty-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%). CONCLUSIONS: The 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 REGISTRATION: URL: www.clinicaltrials.gov. Unique identifier: NCT00268762. |
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Authors:
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Andrew D Barreto; 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 |
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Publication Detail:
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Type: Journal Article; Research Support, American Recovery and Reinvestment Act; Research Support, N.I.H., Extramural Date: 2012-01-05 |
Journal Detail:
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Title: Stroke; a journal of cerebral circulation Volume: 43 ISSN: 1524-4628 ISO Abbreviation: Stroke Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-02-21 Completed Date: 2012-08-15 Revised Date: 2013-04-15 |
Medline Journal Info:
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Nlm Unique ID: 0235266 Medline TA: Stroke Country: United States |
Other Details:
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Languages: eng Pagination: 770-5 Citation Subset: IM |
Affiliation:
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Department of Neurology, University of Texas–Houston Medical School, Houston, TX, USA. andrew.d.barreto@uth.tmc.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00268762 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Anticoagulants / adverse effects*, therapeutic use* Antithrombins / adverse effects*, therapeutic use* Brain Ischemia / complications, therapy Cerebral Arteries / pathology Cerebral Hemorrhage / chemically induced, epidemiology Cerebral Veins / pathology Drug Therapy, Combination Female Humans Male Middle Aged Partial Thromboplastin Time Pilot Projects Pipecolic Acids / adverse effects*, therapeutic use* Stroke / drug therapy*, etiology Tissue Plasminogen Activator / adverse effects*, therapeutic use* Treatment Outcome Ultrasonography, Doppler, Transcranial |
| Grant Support | |
ID/Acronym/Agency:
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1K23NS02229-01/NS/NINDS NIH HHS; 1P50NS044227/NS/NINDS NIH HHS; K23 NS002229-01/NS/NINDS NIH HHS; KL2 RR024149/RR/NCRR NIH HHS; KL2 RR024149-05/RR/NCRR NIH HHS; P50 NS044227-01/NS/NINDS NIH HHS; P50NS044227/NS/NINDS NIH HHS; T32 NS007412-01A1/NS/NINDS NIH HHS; T32NS07412/NS/NINDS NIH HHS; TL1 RR024147/RR/NCRR NIH HHS; UL1 RR024148/RR/NCRR NIH HHS; UL1 RR024148-05/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anticoagulants; 0/Antithrombins; 0/Pipecolic Acids; 74863-84-6/argatroban; EC 3.4.21.68/Tissue Plasminogen Activator |
| Comments/Corrections | |
Comment In:
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Stroke. 2012 Mar;43(3):623-4
[PMID:
22223236
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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