Clinical trial NCT01586702: Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mini-Stroke
Keywords: Stroke, TIA, secondary prevention, support program, multifactorial intervention
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University of Erlangen-Nürnberg Medical School
name: Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München
name: Technische Universität Berlin
name: Aarhus University Hospital
name: Klinikum Ludwigshafen
name: Vivantes Auguste-Viktoria-Klinikum
name: Vivantes Clinic Neukölln
First posted: 2012-04-27
Enrollment: 2082
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute cerebrovascular event (either TIA or minor Stroke within 14 days before study inclusion) according to the following definitions:
* TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
* Minor stroke (mRankin ≤2 at time of inclusion)
* Patients with at least one of the following treatable risk factors:
* Arterial Hypertension
* Diabetes mellitus
* Atrial Fibrillation
* Smoking
* Written informed consent prior to study inclusion
* Realistic perspective in keeping the outpatient appointments

Exclusion Criteria:

* Distance from home to study center not in suitable range for keeping the outpatient appointments
* cognitive impairment jeopardizing adherence to the support program
* Modified Rankin Score \>2 at time of study inclusion
* Malignant disease with life expectancy of less than 3 years
* relevant alcohol or other substance abuse (except for nicotine)
* Stroke or TIA etiology without options for evidence based secondary prevention (e.g. dissection or vasculitis)

Primary outcomes:
measure: Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death
timeFrame: Up to 6 years from inclusion
Secondary outcomes:
measure: Non vascular death
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
measure: Other vascular diseases leading to hospital admission (excl. primary outcome measure)
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
measure: All hospital admissions with vascular intervention (intraarterial or surgical)
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
measure: Bleedings
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
measure: Level of dependency
timeFrame: Up to 6 years from inclusion
measure: All hospital admissions
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
measure: Days alive and at home
timeFrame: Participants will be followed-up for an average of approximately 3.5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept. of Neurology, Charité Universitätsmedizin Berlin
Study officials:
affiliation: Center for Stroke Research, Charité Universitaetsmedizin Berlin
name: Heinrich J Audebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ihl T, Ahmadi M, Laumeier I, Steinicke M, Ferse C, Klyscz P, Endres M, Hastrup S, Poppert H, Palm F, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Audebert HJ. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial. Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15.
citation: Ahmadi M, Laumeier I, Ihl T, Steinicke M, Ferse C, Endres M, Grau A, Hastrup S, Poppert H, Palm F, Schoene M, Seifert CL, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Algra A, Amarenco P, Greving JP, Busse O, Kohler F, Marx P, Audebert HJ. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial. Lancet Neurol. 2020 Jan;19(1):49-60. doi: 10.1016/S1474-4422(19)30369-2. Epub 2019 Nov 7.
citation: Leistner S, Michelson G, Laumeier I, Ahmadi M, Smyth M, Nieweler G, Doehner W, Sobesky J, Fiebach JB, Marx P, Busse O, Kohler F, Poppert H, Wimmer ML, Knoll T, Von Weitzel-Mudersbach P, Audebert HJ. Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial. BMC Neurol. 2013 Jan 24;13:11. doi: 10.1186/1471-2377-13-11.
citation: Leistner S, Benik S, Laumeier I, Ziegler A, Nieweler G, Nolte CH, Heuschmann PU, Audebert HJ. Secondary prevention after minor stroke and TIA - usual care and development of a support program. PLoS One. 2012;7(12):e49985. doi: 10.1371/journal.pone.0049985. Epub 2012 Dec 17.