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

NCT01586702 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2082

Last updated 2019-07-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER
  • University of Erlangen-Nürnberg Medical School

    collaborator OTHER
  • Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München

    collaborator UNKNOWN
  • Technische Universität Berlin

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Klinikum Ludwigshafen

    collaborator OTHER
  • Vivantes Auguste-Viktoria-Klinikum

    collaborator UNKNOWN
  • Vivantes Clinic Neukölln

    collaborator OTHER
  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Heinrich J Audebert, MD · Center for Stroke Research, Charité Universitaetsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2018-12-31
Completion
2019-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586702 on ClinicalTrials.gov