Document Detail


Effect of intravenous tirofiban and aspirin in reducing short-term and long-term neurologic deficit in patients with ischemic stroke: a double-blind randomized trial.
MedLine Citation:
PMID:  20090319     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Thrombolysis with rt-PA is the only approved pharmacological therapy for acute ischemic stroke presently administrable in a 3-hour window (very recently extended to 4.5 h). After this time, the choice is limited to endovascular treatment and antiplatelet drugs, mainly aspirin (ASA), the efficacy of which in the acute phase of stroke has poorly been evaluated. We compared the efficacy of tirofiban, a GP-IIb/IIIa inhibitor, and ASA, with both drugs being administered within 6 h. METHODS: 150 patients were randomly assigned to treatment with tirofiban or ASA, both given for 3 days in a double-blind regimen. Major inclusion criteria were stroke onset within 6 h and a baseline National Institute of Health Stroke Scale (NIHSS) score of 5-25. Outcome variables were the proportion of patients with a NIHSS score reduction of > or =4 points after 72 h, and the proportion of patients with an mRS score of 0-1 at 3 months. RESULTS: The trial, originally planned to enroll 300 patients, was halted after enrollment of 150 patients at interim analysis due to the lack of a trend difference between the 2 treatment groups. Neurological improvement at 72 h was observed in 56% of the patients in each group. At the 3-month follow-up, minimal or absent disability was seen in 45% of the patients in the tirofiban group and 53% in the ASA group; these differences were not statistically significant. Three-month mortality was the same in both groups (10.6%); the rates of symptomatic intracranial hemorrhage were 1% (tirofiban) and 4% (ASA). CONCLUSION: In spite of the fact that the null hypothesis was not supported by our data, we found results supporting the safety (and potential efficacy) of ASA and tirofiban when used in the first hours of acute ischemic stroke. However, this needs to be confirmed by further studies.
Authors:
G Torgano; B Zecca; V Monzani; A Maestroni; P Rossi; M Cazzaniga; D Manganaro; C Boiti; E Zilioli; G Borutti; F Falaschi; C Mandelli
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2010-01-15
Journal Detail:
Title:  Cerebrovascular diseases (Basel, Switzerland)     Volume:  29     ISSN:  1421-9786     ISO Abbreviation:  Cerebrovasc. Dis.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-12     Completed Date:  2010-04-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9100851     Medline TA:  Cerebrovasc Dis     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  275-81     Citation Subset:  IM    
Copyright Information:
Copyright 2010 S. Karger AG, Basel.
Affiliation:
Department of Emergency Medicine, Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena, Milano, Italy. giuseppe.torgano@policlinico.mi.it
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Aspirin / administration & dosage*,  adverse effects
Brain Ischemia / complications,  drug therapy*,  mortality,  physiopathology
Chi-Square Distribution
Disability Evaluation
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Early Termination of Clinical Trials
Female
Fibrinolytic Agents / administration & dosage*,  adverse effects
Hospital Mortality
Humans
Intracranial Hemorrhages / etiology
Italy
Male
Middle Aged
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
Recovery of Function
Stroke / drug therapy*,  etiology,  mortality,  physiopathology
Time Factors
Treatment Outcome
Tyrosine / administration & dosage,  adverse effects,  analogs & derivatives*
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 144494-65-5/tirofiban; 50-78-2/Aspirin; 55520-40-6/Tyrosine

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


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