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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2082 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-05-31

Brief Summary

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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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Detailed Description

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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

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Mini-Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Patient centered structured support program

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Intensified secondary prevention

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No