• Thomas Toell, Christian Boehme, Lukas Mayer, Stefan Krebs, Clemens Lang, Karin Willeit, Barbara Prantl, Michael Knoflach, Gerhard Rumpold, Gudrun Schoenherr, Andrea Griesmacher, Peter Willeit, Julia Ferrari, Wilfried Lang, Stefan Kiechl, and Johann Willeit.
• Department of Neurology, Medical University of Innsbruck, Anichstraße 35, A-6020, Innsbruck, Austria.
• Bmc Neurol. 2018 Nov 6; 18 (1): 187.

BackgroundPatients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended by international guidelines. Moreover, stroke is a leading cause of disability and morbidity which partly emerges from post-stroke complications.Methods/DesignWe designed a block-randomised (2:1 ratio) open pragmatic trial [NCT02156778] with blinded outcome assessment comparing STROKE-CARD to usual post-stroke-patient care. STROKE-CARD is a multifaceted post-stroke disease management program with the objective of reducing recurrent cardiovascular events and improving quality of life in ischaemic stroke and TIA-patients. It combines intensified multi-domain secondary prevention, systematic detection and treatment of post-stroke complications, and patient self-empowerment. Enrolment of 2160 patients with acute ischaemic stroke or TIA (ABCD2-Score ≥ 3) is planned at two study centres in Austria. The co-primary efficacy endpoints are (i) the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) occurring within 12 months after the index event and (ii) one-year health-related quality-of-life measured with the European Quality of Life-5 Dimensions (EQ-5D-3 L) questionaire. Secondary endpoints include all-cause mortality, functional outcome, and target-level achievement in risk factor management.DiscussionThis trial will provide evidence on whether the pragmatic post-stroke intervention program STROKE-CARD can help prevent cardiovascular events and improve quality-of-life within the setting of a high-quality acute stroke care system. In case of success, STROKE-CARD may be implemented in daily clinical routine and serve as a model for other disease management initiatives.Trial RegistrationClinicalTrials.gov: NCT02156778 . (June 5, 2014, retrospectively registered).

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