Document Detail


Early treatment with aspirin plus extended-release dipyridamole for transient ischaemic attack or ischaemic stroke within 24 h of symptom onset (EARLY trial): a randomised, open-label, blinded-endpoint trial.
MedLine Citation:
PMID:  20060783     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Little is known about the best antiplatelet treatment immediately after ischaemic stroke or transient ischaemic attack (TIA). The EARLY trial aimed to compare outcome in patients given aspirin plus extended-release dipyridamole twice daily either within 24 h of stroke or TIA or after 7 days of aspirin monotherapy.
METHODS: In 46 stroke units in Germany, patients aged 18 years or more who presented with symptoms of an acute ischaemic stroke that caused a measurable neurological deficit (National Institutes of Health stroke scale score < or =20) were randomly assigned to receive 25 mg aspirin plus 200 mg extended-release dipyridamole open-label twice daily or 100 mg aspirin monotherapy open-label once daily for 7 days. Patients were randomised by use of a pseudorandom number generator. All patients were then given open-label aspirin plus extended-release dipyridamole for up to 90 days. The primary endpoint was modified Rankin scale score as recorded by centralised, blinded assessment by telephone (tele-mRS) at 90 days. Vascular adverse events (non-fatal stroke, TIA, non-fatal myocardial infarction, and major bleeding complications) and mortality were assessed in a composite safety and efficacy endpoint. Patients were analysed as treated. This trial is registered, number NCT00562588.
FINDINGS: Between July, 2007, and February, 2009, 543 patients were treated: 283 received early aspirin plus extended-release dipyridamole and 260 received aspirin plus extended-release dipyridamole after 7 days on aspirin. At day 90, 154 (56%) patients in the aspirin plus early extended-release dipyridamole group and 133 (52%) in the aspirin plus later extended-release dipyridamole group had no or mild disability (tele-mRS 0 or 1; difference 4.1%, 95% CI -4.5 to 12.6, p=0.45). 28 patients in the early initiation group and 38 in the late initiation group reached the composite endpoint (hazard ratio 0.73, 95% CI 0.44-1.19 p=0.20).
INTERPRETATION: Early initiation of aspirin plus extended-release dipyridamole within 24 h of stroke onset is likely to be as safe and effective in preventing disability as is later initiation after 7 days.
FUNDING: Boehringer Ingelheim.
Authors:
Reinhard Dengler; Hans-Christoph Diener; Andreas Schwartz; Martin Grond; Helmut Schumacher; Thomas Machnig; Christoph Cyrill Eschenfelder; Joachim Leonard; Karin Weissenborn; Andreas Kastrup; Roman Haberl;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-01-07
Journal Detail:
Title:  The Lancet. Neurology     Volume:  9     ISSN:  1474-4465     ISO Abbreviation:  Lancet Neurol     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-04     Completed Date:  2010-02-26     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101139309     Medline TA:  Lancet Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  159-66     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 Elsevier Ltd. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00562588
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Analysis of Variance
Aspirin / therapeutic use*
Dipyridamole / therapeutic use*
Double-Blind Method
Drug Combinations
Female
Germany
Humans
Ischemic Attack, Transient / complications,  drug therapy*
Logistic Models
Male
Middle Aged
Platelet Aggregation Inhibitors / therapeutic use*
Severity of Illness Index
Time Factors
Chemical
Reg. No./Substance:
0/Drug Combinations; 0/Platelet Aggregation Inhibitors; 0/aspirin, dipyridamole drug combination; 64ALC7F90C/Dipyridamole; R16CO5Y76E/Aspirin
Investigator
Investigator/Affiliation:
J Berrouschot / ; A Stoll / ; G W Ickenstein / ; T Westendorf / ; M Daffertshofer / ; B Lachenicht / ; A Szponar-Wolf / ; P Krauseneck / ; P Oschmann / ; M Pott / ; K Schultes / ; K Wessel / ; A Ahlers / ; D G Nabavi / ; O Crome / ; M Endres / ; J G Jungehülsing / ; M Ebke / ; A Schröter / ; P Odin / ; M von Mering / ; W Heide / ; J R Hanssen / ; J Schrader / ; S Lüders / ; G Rudel / ; S Jander / ; M Siebler / ; P Schellinger / ; P Berlit / ; H -C Diener / ; U Johansson / ; C Weimer / ; W D Niesen / ; A Schläger / ; A Jacobs / ; C Hohmann / ; A Kastrup / ; K Gröschel / ; S Schnaudigel / ; K Wasser / ; C Terborg / ; P P Urban / ; C Pohlman / ; E Kaczmarek / ; J Koehler / ; A Müller-Jensen / ; M Rosenkranz / ; R Dengler / ; A Goldbecker / ; H Worthmann / ; M Eicke / ; O W Witte / ; T Ringer / ; A Müller / ; J Wöhrle / ; J Sobesky / ; D Schneider / ; D Michalski / ; C Hobohm / ; G Seidel / ; J Marx / ; S Klimpe / ; M Hamer / ; J Haan / ; G Greif / ; A Al-Khalaf / ; M Dichgans / ; Y Mewald / ; H Poppert / ; W -R Schäbitz / ; M Nückel / ; E Stark / ; F Schlachetzki / ; S Boy / ; P von Heinemann / ; J Mühler / ; T Fortwängler / ; E Schmid / ; O Menn / ; M Jauk / ; A Luft / ; R Huber / ; S Müller / ; L Cepek / ; R Dengler / ; H -C Diener / ; A Schwartz / ; M Grond / ; H Schumacher / ; T Machnig / ; C C Eschenfelder / ; J Leonard / ; K Weissenborn / ; A Kastrup / ; R Haberl / ; R Dengler / ; H Schumacher / ; J Leonard / ; H Schumacher / ; T Machnig / ; C C Eschenfelder / ; J Leonard / ; M Mateblowski / ; M Grond / ; J Schenkel /

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


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