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

Mini-Stroke Clinical Trial

— INSPiRE-TMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586702
• Other study ID #: EA2/084/11
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2082
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mini-Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Dept. of Neurology, Charité Universitätsmedizin Berlin	Berlin

Sponsors (9)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Aarhus University Hospital, Klinikum Ludwigshafen, Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, München, Technische Universität Berlin, Technische Universität München, University of Erlangen-Nürnberg Medical School, Vivantes Auguste-Viktoria-Klinikum, Vivantes Klinikum Neukölln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death	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	Up to 6 years from inclusion
Secondary	Non vascular death		Participants will be followed-up for an average of approximately 3.5 years
Secondary	Other vascular diseases leading to hospital admission (excl. primary outcome measure)	Consisting of TIA, Angina pectoris, PAD with vascular intervention	Participants will be followed-up for an average of approximately 3.5 years
Secondary	All hospital admissions with vascular intervention (intraarterial or surgical)		Participants will be followed-up for an average of approximately 3.5 years
Secondary	Bleedings	All bleedings leading to therapeutic intervention (categorized according to GUSTO definitions)	Participants will be followed-up for an average of approximately 3.5 years
Secondary	Level of dependency	Assessment according to modified Rankin Score and level of care (German care insurance)	Up to 6 years from inclusion
Secondary	All hospital admissions		Participants will be followed-up for an average of approximately 3.5 years
Secondary	Days alive and at home		Participants will be followed-up for an average of approximately 3.5 years