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Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS)

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ClinicalTrials.gov Identifier: NCT01586702
Recruitment Status : Active, not recruiting
First Posted : April 27, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Technische Universität München
University of Erlangen-Nürnberg Medical School
Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München
Technische Universität Berlin
Aarhus University Hospital
Klinikum Ludwigshafen
Vivantes Auguste-Viktoria-Klinikum
Vivantes Klinikum Neukölln
Information provided by (Responsible Party):
Heinrich J Audebert, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Mini-Stroke Behavioral: Patient centered structured support program Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2082 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : September 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
No Intervention: Regular care
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.
Active Comparator: Support program
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

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 Name: Intensified secondary prevention




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586702


Locations
Germany
Dept. of Neurology, Charité Universitätsmedizin Berlin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Technische Universität München
University of Erlangen-Nürnberg Medical School
Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München
Technische Universität Berlin
Aarhus University Hospital
Klinikum Ludwigshafen
Vivantes Auguste-Viktoria-Klinikum
Vivantes Klinikum Neukölln
Investigators
Principal Investigator: Heinrich J Audebert, MD Center for Stroke Research, Charité Universitaetsmedizin Berlin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heinrich J Audebert, Head of Neurology at Campus Benjamin Franklin, Clinical Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01586702     History of Changes
Other Study ID Numbers: EA2/084/11
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Heinrich J Audebert, Charite University, Berlin, Germany:
Stroke, TIA, secondary prevention, support program, multifactorial intervention

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases