Diener, Hans Christoph and Ringelstein, Erich Bernd and von Kummer, Rüdiger and Langohr, Hans Dieter and Bewermeyer, Heiko and Landgraf, Helmut and Hennerici, Michael and Welzel, Dieter and Graeve, Michael and Brom, Joachim and Weidinger, Gottfried (2001) Treatment of acute ischemic stroke with the low-molecular-weight heparin certoparin: Results of the TOPAS trial. STROKE, 32 (1). pp. 22-29. ISSN 0039-2499, 1524-4628
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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 greater than or equal to 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 greater than or equal to 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PLACEBO-CONTROLLED TRIAL; COOPERATIVE ACUTE STROKE; THROMBOLYTIC THERAPY; ASPIRIN; DAMAGE; ECASS; heparin; stroke, acute; stroke, ischemic; stroke management; thrombosis |
| Subjects: | 600 Technology > 615 Pharmacy |
| Divisions: | Chemistry and Pharmacy > Institute of Pharmacy > Pharmacology and Toxicology (Prof. Schlossmann, formerly Prof. Seifert) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 08 Mar 2022 07:15 |
| Last Modified: | 08 Mar 2022 07:15 |
| URI: | https://pred.uni-regensburg.de/id/eprint/41948 |
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