Hostname: page-component-8448b6f56d-c47g7 Total loading time: 0 Render date: 2024-04-20T00:01:27.959Z Has data issue: false hasContentIssue false

Methodology for the Canadian Activase for Stroke Effectiveness Study (CASES)

Published online by Cambridge University Press:  02 December 2014

Michael D. Hill
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Foothills, Medical Centre, Seaman Family MR Centre, Calgary, AB, Canada
Alastair M. Buchan
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Foothills, Medical Centre, Seaman Family MR Centre, Calgary, AB, Canada
The CASES Investigators
Affiliation:
Department of Clinical Neurosciences, University of Calgary, Foothills, Medical Centre, Seaman Family MR Centre, Calgary, AB, Canada
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Background:

Intravenous recombinant tissue plasminogen activator (tPA, alteplase) was conditionally licensed for the treatment of acute ischemic stroke (AIS) in Canada on February 17, 1999. As a condition of licensure, the Canadian Activase for Stroke Effectiveness Study (CASES) was established to monitor the use of alteplase for AIS in Canada. The study involves multiple stakeholders.

Methods:

CASES is a prospective registry of patients treated with alteplase for AIS. The purposes of this registry are to ensure the safety of the drug in the Canadian context, to assess effectiveness of alteplase for AIS and to gather further information to try to establish which patients are most likely to benefit from treatment.

Results:

Both community (n=25) and tertiary centres (n=35) have enrolled a total of 944 patients to date. Early results suggest that thrombolytic stroke treatment is both safe and effective among these centres.

Conclusion:

This paper outlines the development of and methods for the CASES study. The study is an example of a multi-stakeholder collaboration to advance the care of patients with acute stroke.

Résumé:

RÉSUMÉ:Introduction:

L'activateur du plasminogène tissulaire recombinant (tPA, alteplase) administré par voie intraveineuse a été approuvé sous condition pour le traitement de l'accident vasculaire cérébral ischémique (AVCI) au Canada le 17 février 1999. L'Étude Canadienne sur l'efficacité d'activase dans le traitement de l'AVCI a été établie pour surveiller l'utilisation de l'alteplase dans le traitement de l'AVCI aigu afin de satisfaire à une condition de l'approbation. L'étude implique plusieurs partenaires.

Méthodes:

CASES est un registre prospectif de patients traités par l'alteplase pour un AVCI aigu. Les buts de ce registre sont de s'assurer de la sécurité du médicament dans le contexte Canadien, d'évaluer l'efficacité de l'alteplase dans le traitement de l'AVCI aigu et d'amasser plus d'informations pour déterminer quels patients sont susceptibles de bénéficier davantage de ce traitement.

Résultats:

Des centres de soins communautaires (n = 25) et tertiaires (n = 35) ont enregistré au total 944 patients à date. Les résultats préliminaires suggèrent que le traitement thrombolytique de l'AVC est sécuritaire et efficace dans ces centres.

Conclusions:

Cet article décrit le développement et les méthodes de l'étude CASES. Cette étude est un exemple d'une collaboration de plusieurs partenaires pour l'avancement des soins chez des patients atteints d'AVC aigu.

Type
Research Article
Copyright
Copyright © The Canadian Journal of Neurological 2001

References

1. NINDS tPA Stroke Study Group. Tissue plasminogen activator foracute ischemic stroke. New Eng J Med 1996; 333: 15811587.Google Scholar
2. European Cooperative Acute Stroke Study (ECASS): Intravenousthrombolysis with tPAfor acute hemispheric stroke. JAMA 1995; 274: 10171025.Google Scholar
3. Hacke, W, Kaste, M, Fieschi, C, et al for the ECASS-2 Investigators.Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischemic stroke (ECASS-2). Lancet 1998; 352: 12451251.Google Scholar
4. Clark, WM, Wiseman, S, Albers, GW, et al for the ATLANTISInvestigators. Recombinant tissue-type plasminogen activator for ischemic stroke within 3-5h of symptom onset. JAMA 1999; 282: 20192026.Google Scholar
5. Grotta, J. Should thrombolytic therapy be the first-line treatment foracute ischemic stroke? t-PA - the best current option for mostpatients. N Engl J Med 1997;337(18):13101313.Google Scholar
6. Caplan, LR, Mohr, JP, Kistler, JP, Koroshetz, W. Should thrombolytictherapy be the first-line treatment for acute ischemic stroke? Thrombolysis - not a panacea for ischemic stroke. N Engl J Med 1997;337(18):13091310; discussion 1313.Google Scholar
7. Hachinski, V. Thrombolysis in stroke: between the promise and theperil. JAMA 1996;276(12):995996.CrossRefGoogle Scholar
8. Hoffman, JR. Predicted impact of intravenous thrombolysis. Anothertrial is needed. Br Med J 2000; 320:1007.Google Scholar
9. Hoffman, JR. Should physicians give tPA to patients with acuteischemic stroke? Against: and just what is the emperor of stroke wearing? West J Med 2000;173:149150.Google Scholar
10. Wardlaw, JM, del Zoppo, G, Yamaguchi, T. Thrombolysis for acuteischemic stroke. The Cochrane Library 1999 Issue 4.Google Scholar
11. Anonymous. Canadian Adverse DrugReaction Newsletter:Alteplase (Activase rt-PA) for acute ischemic stroke: special precautions for new indication. CMAJ 1999;161:7374. Google Scholar
12. Anonymous. The Changing Face of Heart Disease and Stroke inCanada 2000. Heart and Stroke Foundation of Canada. Ottawa,Canada 1999.Google Scholar
13. Norris, JW, Buchan, A, Cote, R, et al for the Canadian StrokeConsortium. Canadian guidelines for intravenous thrombolytic treatment of acute stroke. Can J Neurol Sci 1998;25:257259.Google Scholar
14. Hill, MD, Barber, PA, Takahashi, JL, et al. Anaphylactoid reactionsand angioedema during alteplase treatment of acute ischemic stroke. Can Med Assc J 2000;162:12811284.Google Scholar
15. Hornig, CR, Bauer, T, Simon, C, Trittmacher, S, Dorndorf, W. Hemorrhagic transformation in cardioembolic cerebral infarction. Stroke 1993;24:465468.Google Scholar
17. Demchuk, AM, Karbalai, H, Grotta, JC, Buchan, AM. Early CTscoring system predicts hemorrhage and outcome after intravenous thrombolytic therapy (abstract). Stroke 1999;30:248.Google Scholar
18. Teyerberg, EW, Eijkemans, MJC, Habbema, JDF. Stepwise selectionin small data sets: a simulation study of bias in logistic regressionanalysis. J Clin Epidemiol 1999;52:935942.CrossRefGoogle Scholar
19. Hill, MD, Woolfenden, A, Teal, P, Buchan, AM. Intravenous alteplasefor acute ischemic stroke: the Canadian Experience. The StrokeInterventionalist 2000;2:57.Google Scholar
20. Hill, MD, Buchan, AM for the CASES Investigators. The CanadianActivase for Stroke Effectiveness Study (CASES): Interim results (Abstract). Stroke 2001;32:323.Google Scholar
21. Buchan, AM, Barber, PA, Newcommon, N, et al. Effectiveness of tPAin acute ischemic stroke: outcome relates to appropriateness. Neurology 2000;54:679684.Google Scholar
22. Rochon, PA, Anderson, GM, Tu, JV, et al. Use of B-blocker therapy inolder patients after acute myocardial infarction in Ontario. CMAJ 1999;161:14031408.Google Scholar
23. Grond, M, Stenzel, C, Schmulling, S, et al. Early intravenousthrombolysis for acute ischemic stroke in a community-based approach. Stroke 1998;29(8):15441549.Google Scholar
24. Tanne, D, Bates, VE, Verro, P, et al. Initial clinical experience with IVtissue plasminogen activator for acute ischemic stroke: a multi-center survey. The t-PA Stroke Survey Group. Neurology 1999; 53(2):424427.Google Scholar
25. Albers, GW, Bates, VE, Clark, WM, et al. Intravenous tissue-typeplasminogen activator for treatment of acute stroke. JAMA 2000;283:11451150.CrossRefGoogle ScholarPubMed
26. Chiu, D, Krieger, D, Villar-Cordova, C, et al. Intravenous tissueplasminogen activator for acute ischemic stroke: feasibility, safety, and efficacy in the first year of clinical practice. Stroke 1998;29(1):1822.Google Scholar
27. Battista, RN. Innovation and diffusion of health-relatedtechnologies. Int J Technol Assess Health Care 1989;5:227248.Google Scholar
28. Weingart, SN. Acquiring advanced technology: decision-makingstrategies at twelve medical centres. Int J Technol Assess HealthCare 1993;9:530538.Google Scholar