Mini-Stroke Clinical Trial
Official title:
Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) A Randomized Trial Comparing a Patient Centered Support Program Versus Conventional Car
Patients after TIA or Stroke are at high risk of experiencing a new stroke or myocardial infarction. Poor adherence to evidence based secondary prevention regimens is frequently seen. Support programs for patients may not only improve adherence to recommended therapies but also reduce the recurrence rate of stroke and heart attack. The investigators hypothesize that compared to regular care, a structured and patient centered secondary prevention program will lead to a relative risk reduction of at least 28% of recurrent vascular events.
Although effective methods of secondary prevention after stroke or TIA are available,
adherence to recommended evidence-based treatments is often poor. Programs for supported
secondary prevention after cerebrovascular events with improved health education are
promising but have not been evaluated regarding recurrent event reduction so far.
A prospective randomized trial has been started to assess the effectiveness of a patient
centered structured support program intending a reduction of recurrent vascular events. Usual
care consists of structured information given at discharge as well as regular outpatient care
by general practitioners. The support program additionally employs a stepwise intensified
support program with up to eight appointments over two years in outpatient clinics. Results
of risk factor measurements and assessed adherence to medical recommendations are shared with
the patients. They are also offered assistance in finding appropriate physical activities or
smoking cessation programs.
Patients are randomized to regular care or regular care plus support program and will be
followed-up until the total number of 317 primary endpoints has been reached. The composite
primary endpoint consists of stroke, major coronary event and vascular death.
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