Document Detail

Prophylaxis of thrombotic and embolic events in acute ischemic stroke with the low-molecular-weight heparin certoparin: results of the PROTECT Trial.
MedLine Citation:
PMID:  16306456     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND PURPOSE: Patients with stroke are at substantial risk of thromboembolic complications and therefore require antithrombotic prophylaxis. To show the noninferiority of the low-molecular-weight heparin certoparin to unfractionated heparin (UFH) for the prevention of thromboembolic complications, we performed a randomized, double-blind, active-controlled multicenter trial in patients with acute ischemic stroke. METHODS: Overall, 545 patients were randomized within 24 hours of stroke onset to treatment with certoparin (3000 U anti-Xa OD; n=272) or UFH (5000 U TID; n=273) for 12 to 16 days. Patients with paresis of a leg and an National Institutes of Health Stroke Scale score of 4 to 30 points were included. The primary end point was a composite outcome of proximal deep vein thrombosis, pulmonary embolism, or death related to venous thromboembolism during treatment. Computed tomography was performed at trial entry, after 7 days, and when clinical deterioration occurred. RESULTS: The per-protocol analysis revealed 17 (7.0%) primary events in the certoparin group compared with 24 (9.7%) in the UFH group, thereby demonstrating noninferiority (P=0.0011), confirmed by intention-to-treat analysis (6.6% versus 8.8%; P=0.008). Major bleeding occurred during treatment in 3 patients allocated to certoparin (1.1%) and 5 patients allocated to UFH (1.8%). CONCLUSIONS: Certoparin (3000 U anti-Xa OD) is at least as effective and safe as UFH (TID) for the prevention of thromboembolic complications in patients with acute ischemic stroke.
Hans-Christoph Diener; Erich B Ringelstein; Rüdiger von Kummer; Helmut Landgraf; Klaus Koppenhagen; Job Harenberg; Ivan Rektor; Attila Csányi; Dietmar Schneider; Jürgen Klingelhöfer; Joachim Brom; Gottfried Weidinger;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2005-11-23
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  37     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2006 Jan 
Date Detail:
Created Date:  2005-12-23     Completed Date:  2006-02-21     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  139-44     Citation Subset:  IM    
University of Essen, Germany.
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MeSH Terms
Aged, 80 and over
Double-Blind Method
Heparin / therapeutic use*
Heparin, Low-Molecular-Weight / therapeutic use*
Ischemia / therapy
Middle Aged
Models, Statistical
Pulmonary Embolism / drug therapy,  mortality
Severity of Illness Index
Stroke / drug therapy*,  mortality,  pathology
Thromboembolism / drug therapy*,  mortality,  pathology
Time Factors
Tomography, X-Ray Computed
Treatment Outcome
Venous Thrombosis / drug therapy
Reg. No./Substance:
0/Heparin, Low-Molecular-Weight; 0/certoparin; 9005-49-6/Heparin

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

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