Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients

NCT01586702 | Completed DMC

• 1 other identifier: EA2/084/11
• Study Type: interventional
• Target: 2,082
• Locations: 1 country
• Sites: 1

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.

Conditions

Mini-Stroke

Keywords

Stroke, TIA, secondary prevention, support program, multifactorial intervention

Outcome Measures

Primary Outcomes (1)

• Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death

  Stroke: Acute (focal-) neurological syndrome, caused by brain infarction or intracerebral hemorrhage Major coronary event:Including instable Angina pectoris, STEMI and non-STEMI Vascular death: Caused by stroke (within 30 days of event), or major coronary event (within 7 days of event), or non-cerebral hemorrhage, or by peripheral arterial disease 30 days after vascular event or vascular intervention (intraarterial or surgical), or by pulmonary embolism or sudden death if death occurs within 24 hours in a patients with previously stable and healthy state if no non-vascular cause is documented

  Up to 6 years from inclusion

Secondary Outcomes (7)

• Non vascular death

  Participants will be followed-up for an average of approximately 3.5 years

• Other vascular diseases leading to hospital admission (excl. primary outcome measure)

  Participants will be followed-up for an average of approximately 3.5 years

• All hospital admissions with vascular intervention (intraarterial or surgical)

  Participants will be followed-up for an average of approximately 3.5 years

• Bleedings

  Participants will be followed-up for an average of approximately 3.5 years

• Level of dependency

  Up to 6 years from inclusion

Study Arms (2)

Regular care

NO INTERVENTION

Consisting of structured information given at hospital discharge regarding stroke etiology and recommended secondary prevention plus regular outpatient care by general practitioners or family doctors.

Support program

ACTIVE COMPARATOR

In addition to regular care: Up to 8 appointments in outpatient clinics. Results of risk factor measurements and assessed adherence to medical recommendations are shared with the patients. In case that a patients fails to meet target values, preventive measures will be modified directly or via recommendation to GPs / family doctors. Patients are also offered assistance in finding appropriate physical activities or smoking cessation programs.

Behavioral: Patient centered structured support program

Interventions

Patient centered structured support program BEHAVIORAL

Behavioural: Structured support program Program with up to 8 outpatient appointments focusing on: * Measurement of risk factors * Assessment of medication intake * Monitoring of antithrombotic therapy * Joint agreement of an individual target plan Target values for risk factors: * Blood pressure \< 140/85 mmHg (\<130/80 in diabetics), normal circadian profile * HbA1c \<7.5% * Nicotine abstinence * LDL \< 100mg/dl (\< 70mg/dl in high risk patients) * Physical activity ≥ 30min \>2 x / week Targets for pharmaceutical treatment: * Platelet inhibitors for strokes / TIA of arterial etiology * Combined platelet inhibition over 3 months in symptomatic intra- or extracranial stenosis * Cumarins (INR 2-3) or new oral anticoagulants in AF patients * Statin treatment in patients with LDL \>100mg/dl Intervention strategies: • According to Motivational Interviewing

Also known as: Intensified secondary prevention

Support program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TIA (clinical restitution within 24 hours and ABCD2-Score ≥3) or visible DWI-lesion in MRI
• Patients with at least one of the following treatable risk factors:
• Arterial Hypertension
• Diabetes mellitus
• Atrial Fibrillation
• Smoking
• Realistic perspective in keeping the outpatient appointments

You may not qualify if:

• Distance from home to study center not in suitable range for keeping the outpatient appointments
• cognitive impairment jeopardizing adherence to the support program
• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Technical University of Munich: collaborator
• University of Erlangen-Nürnberg Medical School: collaborator
• Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München: collaborator
• Technische Universität Berlin: collaborator
• Aarhus University Hospital: collaborator
• Klinikum Ludwigshafen: collaborator
• Vivantes Auguste-Viktoria-Klinikum: collaborator
• Vivantes Clinic Neukölln: collaborator

Study Sites (1)

Dept. of Neurology, Charité Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

Related Publications (5)

• Stegemann A, Rios AS, Khalil A, Grittner U, Temuulen U, Ganeshan R, Braemswig TB, Horn A, Ihl T, Audebert HJ, Kufner A, Endres M. Neuroimaging Correlates of Post-Stroke Pain After Ischemic Stroke: Secondary Analysis of the INSPiRE-TMS Trial. medRxiv [Preprint]. 2025 Aug 11:2025.08.07.25333248. doi: 10.1101/2025.08.07.25333248.

  PMID: 40832386 DERIVED

• 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.

  PMID: 35703097 DERIVED

• 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.

  PMID: 31708447 DERIVED

• 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.

  PMID: 23347503 DERIVED

• 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.

  PMID: 23284630 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Heinrich J Audebert, MD

  Center for Stroke Research, Charité Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology at Campus Benjamin Franklin, Clinical Professor

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 27, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

DE (1)