Prophylaxis of thrombotic and embolic events in acute ischemic stroke with the low-molecular-weight heparin Certoparin
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 compli...
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| Main Authors: | , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2006
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| In: |
Stroke
Year: 2006, Volume: 37, Issue: 1, Pages: 139-144 |
| ISSN: | 1524-4628 |
| DOI: | 10.1161/01.STR.0000195182.67656.ee |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1161/01.STR.0000195182.67656.ee Verlag, lizenzpflichtig, Volltext: https://www.ahajournals.org/doi/10.1161/01.STR.0000195182.67656.ee |
| Author Notes: | 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 |
| Summary: | 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. |
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| Item Description: | Published online November 23, 2005 Gesehen am 14.04.2022 |
| Physical Description: | Online Resource |
| ISSN: | 1524-4628 |
| DOI: | 10.1161/01.STR.0000195182.67656.ee |