Treatment of acute ischemic stroke with the low-molecular-weight heparin certoparin

• Verfasst von: Diener, Hans-Christoph [VerfasserIn]
• Verfasst von: Ringelstein, Erich Bernd [VerfasserIn]
• Verfasst von: Kummer, Rüdiger von [VerfasserIn]
• Verfasst von: Langohr, Hans Dieter [VerfasserIn]
• Verfasst von: Bewermeyer, Heiko [VerfasserIn]
• Verfasst von: Landgraf, Helmut [VerfasserIn]
• Verfasst von: Hennerici, Michael G. [VerfasserIn]
• Verfasst von: Welzel, Dieter [VerfasserIn]
• Verfasst von: Gräve, Michael [VerfasserIn]
• Verfasst von: Brom, Joachim [VerfasserIn]
• Verfasst von: Weidinger, Gottfried [VerfasserIn]
• Titel: Treatment of acute ischemic stroke with the low-molecular-weight heparin certoparin
• Titelzusatz: results of the TOPAS trial
• Verf.angabe: 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
• E-Jahr: 2001
• Jahr: [January 2001]
• Umfang: 8 S.
• Fussnoten: Gesehen am 31.03.2021
• Titel Quelle: Enthalten in: Stroke
• Ort Quelle: New York, NY : Association, 1970
• Jahr Quelle: 2001
• Band/Heft Quelle: 32(2001), 1 vom: Jan., Seite 22-29
• ISSN Quelle: 1524-4628
• DOI: doi:10.1161/01.STR.32.1.22
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1752962990

Abstract

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.