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.
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.
- 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.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|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|
- Charite University, Berlin, Germany Lead
- Vivantes Klinikum Neukölln
- Technische Universität Berlin
- Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München
- University of Erlangen-Nürnberg Medical School
- Technische Universität München
- Vivantes Auguste-Viktoria-Klinikum
- Berlin University of Technology
- Aarhus University Hospital
- Klinikum Ludwigshafen