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


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov: 01586702.
Department of Neurology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany. stefanie.leistner@charite.de
Stefanie
S
Leistner
Georg
G
Michelson
Inga
I
Laumeier
Michael
M
Ahmadi
Maureen
M
Smyth
Gabriele
G
Nieweler
Wolfram
W
Doehner
Jan
J
Sobesky
Jochen B
JB
Fiebach
Peter
P
Marx
Otto
O
Busse
Friedrich
F
Köhler
Holger
H
Poppert
Martin L J
ML
Wimmer
Thomas
T
Knoll
Paul
P
Von Weitzel-Mudersbach
Heinrich J
HJ
Audebert
D000284:Administration, Oral; D000328:Adult; D000596:Amino Acids / Q000627:therapeutic use*; D000925:Anticoagulants / Q000008:administration & dosage*; D015982:Bias; D018572:Disease-Free Survival; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control*; D008137:Longitudinal Studies; D008875:Middle Aged; D012307:Risk Factors; D018401:Sample Size; D055502:Secondary Prevention; D012720:Severity of Illness Index; D020521:Stroke / Q000517:prevention & control*; D013997:Time Factors; D055815:Young Adult
D000596:Amino Acids; D000925:Anticoagulants; C013165:statine