Document Detail


The argatroban and tissue-type plasminogen activator stroke study: final results of a pilot safety study.
MedLine Citation:
PMID:  22223235     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Journal Article; Research Support, American Recovery and Reinvestment Act; Research Support, N.I.H., Extramural     Date:  2012-01-05
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  43     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-21     Completed Date:  2012-08-15     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  770-5     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00268762
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MeSH Terms
Descriptor/Qualifier:
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:
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/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/RR/NCRR NIH HHS; UL1 RR024148-05/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Antithrombins; 0/Pipecolic Acids; 74863-84-6/argatroban; EC 3.4.21.68/Tissue Plasminogen Activator
Comments/Corrections
Comment In:
Stroke. 2012 Mar;43(3):623-4   [PMID:  22223236 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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