Abstract
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).
Highlights
Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events
STROKE-CARD may be implemented in daily clinical routine and serve as a model for other disease management initiatives
Trial objectives In this trial, we test the hypothesis that the pragmatic disease-management program STROKE-CARD designed for ischaemic stroke and TIA patients is capable of (a) preventing recurrent cardiovascular events by optimised guideline-compliant secondary prevention and target level achievement and (b) ameliorating health-related quality of life (QoL) and patient-wellbeing by early detection and consequent treatment of post-stroke complications
Summary
Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Stroke is a leading cause of disability and morbidity which partly emerges from post-stroke complications. Stroke is the second leading cause of death and one of the leading contributors to disability worldwide [1, 2]. While the age-standardised incidence of stroke is decreasing in high-income countries due to improved health care services and primary prevention, the absolute number of stroke patients is still on the rise, mainly based on continuous population aging and growth [3]. The risk of stroke recurrence is high at up to 10% within one year and more than 25% within 5 years [4]. Recurrent strokes account for about one fifth of all strokes in state-wide registries [5], have a worse clinical outcome, have a higher fatality rate, and cause higher healthcare costs than first-ever strokes [6]
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