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Open Access Study protocol

Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial

Stefanie Leistner1*, Georg Michelson2, Inga Laumeier1, Michael Ahmadi1, Maureen Smyth1, Gabriele Nieweler1, Wolfram Doehner3, Jan Sobesky4, Jochen B Fiebach5, Peter Marx1, Otto Busse6, Friedrich Köhler7, Holger Poppert8, Martin LJ Wimmer9, Thomas Knoll9, Paul Von Weitzel-Mudersbach10 and Heinrich J Audebert5*

Author Affiliations

1 Department of Neurology, Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany

2 Department of Ophthalmology, Universitätsklinikum Erlangen, Maximiliansplatz 2, 91054, Erlangen, Germany

3 Center for Stroke Research Berlin, Department of Neurology, Charité – Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany

4 Center for Stroke Research Berlin, Department of Neurology, Charité – Universitätsmedizin Berlin, Campus Berlin Mitte, Charitéplatz 1, 10117, Berlin, Germany

5 Center for Stroke Research Berlin, Department of Neurology, Charité – Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany

6 Generalsekretaer Deutsche Schlaganfall-Gesellschaft, Reinhardtstrasse 27C, 10117, Berlin, Germany

7 Center for Cardiovascular Telemedicine, Charité – Universitätsmedizin Berlin, Campus Berlin Mitte, Charitéplatz 1, 10117, Berlin, Germany

8 Department of Neurology, Technische Universität München, Klinikum rechts der Isar, Ismaninger Str. 22, 81675, München, Germany

9 Gemeinschaftspraxis Dr.med.Thomas Knoll, Martin L.J.Wimmer und Dr. med. Michael Oppenheimer, Prinzregentenplatz 13, 81675, München, Germany

10 Department of Clinical Medicine - The Department of Neurology, Nørrebrogade 44, 8000, Aarhus C, Denmark

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BMC Neurology 2013, 13:11  doi:10.1186/1471-2377-13-11

Published: 24 January 2013

Abstract

Background

Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA.

Methods/design

Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out).

Discussion

Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed.

Trial registration

clinicaltrials.gov: 01586702

Keywords:
TIA; Stroke; Secondary prevention; Intervention trial