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Completed

NCT Number: NCT01586702

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

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.

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Key information

Conditions

Mini-Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Neurology, Charité Universitätsmedizin Berlin

Berlin, 12200, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Intensified secondary prevention

Primary outcomes

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

    Time frame: Up to 6 years from inclusion

    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

Secondary outcomes

  1. Non vascular death

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

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

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

    Consisting of TIA, Angina pectoris, PAD with vascular intervention

  3. All hospital admissions with vascular intervention (intraarterial or surgical)

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

  4. Bleedings

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

    All bleedings leading to therapeutic intervention (categorized according to GUSTO definitions)

  5. Level of dependency

    Time frame: Up to 6 years from inclusion

    Assessment according to modified Rankin Score and level of care (German care insurance)

  6. All hospital admissions

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

  7. Days alive and at home

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

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

Registry information

Official study 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

Acronym: INSPiRE-TMS

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Apr 27, 2012
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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