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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Patient centered structured support program Behavioral
    Other Names: Intensified secondary prevention
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Support program
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death Up to 6 years from inclusion Yes
Secondary Non vascular death Participants will be followed-up for an average of 3.5 years Yes
Secondary Other vascular diseases leading to hospital admission (excl. primary outcome measure) Participants will be followed-up for an average of 3.5 years Yes
Secondary All hospital admissions with vascular intervention (intraarterial or surgical) Participants will be followed-up for an average of 3.5 years Yes
Secondary Bleedings Participants will be followed-up for an average of 3.5 years Yes
Secondary Level of dependency Up to 6 years from inclusion No
Secondary All hospital admissions Participants will be followed-up for an average of 3.5 years Yes
Secondary Days alive and at home Participants will be followed-up for an average of 3.5 years No

Sponsors