Treatment of acute ischemic stroke with the low-molecular-weight heparin certoparin: results of the TOPAS trial
Background and Purpose—To study the safety and efficacy of the low-molecular-weight heparin certoparin, we performed a randomized, double-blind, dose-finding multicenter trial in patients with acute ischemic stroke (Therapy of Patients With Acute Stroke [TOPAS]).Methods—We randomized 404 patients to...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
[January 2001]
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| In: |
Stroke
Year: 2001, Volume: 32, Issue: 1, Pages: 22-29 |
| ISSN: | 1524-4628 |
| DOI: | 10.1161/01.STR.32.1.22 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1161/01.STR.32.1.22 Verlag, lizenzpflichtig, Volltext: https://www.ahajournals.org/doi/10.1161/01.str.32.1.22 
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| Author Notes: | Hans Christoph Diener, Erich Bernd Ringelstein, Rüdiger von Kummer, Hans Dieter Langohr, Heiko Bewermeyer, Helmut Landgraf, Michael Hennerici, Dieter Welzel, Michael Gräve, Joachim Brom, and Gottfried Weidinger |
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| 245 | 1 | 0 | |a Treatment of acute ischemic stroke with the low-molecular-weight heparin certoparin |b results of the TOPAS trial |c Hans Christoph Diener, Erich Bernd Ringelstein, Rüdiger von Kummer, Hans Dieter Langohr, Heiko Bewermeyer, Helmut Landgraf, Michael Hennerici, Dieter Welzel, Michael Gräve, Joachim Brom, and Gottfried Weidinger |
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| 520 | |a Background and Purpose—To study the safety and efficacy of the low-molecular-weight heparin certoparin, we performed a randomized, double-blind, dose-finding multicenter trial in patients with acute ischemic stroke (Therapy of Patients With Acute Stroke [TOPAS]).Methods—We randomized 404 patients to 4 treatment groups within 12 hours of stroke onset: 3000 U anti-factor Xa (aXa) certoparin once daily (treatment group 1); 3000 U aXa twice daily (group 2); 5000 U aXa twice daily (group 3); and 8000 U aXa twice daily (group 4). The primary efficacy variable was the proportion of patients reaching a favorable functional outcome (Barthel Index ≥90 points) at 3 months. CT was performed at trial entry, after 7 days, and on clinical deterioration.Results—The proportion of patients with Barthel Index ≥90 was not different between treatment arms (61.5%, 60.8%, 63.3%, and 56.3% in the 4 groups, respectively; intent-to-treat population). European Stroke Scale scores improved in all treatment groups within the first 14 days to a similar extent. During the follow-up of 6 months, percentages of patients with recurrent stroke/transient ischemic attack were 11.0%, 5.9%, 9.7%, and 13.0% in the 4 groups, respectively. Overall mortality was only 7.4%. Two parenchymal cerebral hematomas and 1 extracranial bleeding episode occurred in treatment group 1 versus 1 and 0 in group 2, 2 and 0 in group 3, and 4 and 5 in group 4, respectively. During certoparin treatment, 1 deep vein thrombosis but no pulmonary embolism was observed.Conclusions—Dose increase of certoparin up to 8000 U aXa twice daily did not improve the functional outcome of patients with ischemic stroke. Severe bleeding tended to be more frequent in the highest dose group only. | ||
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