Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS)
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|ClinicalTrials.gov Identifier: NCT01586702|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2012
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mini-Stroke||Behavioral: Patient centered structured support program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2082 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
No Intervention: 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.
Active Comparator: 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.
Behavioral: Patient centered structured support program
Behavioural: Structured support program
Program with up to 8 outpatient appointments focusing on:
Target values for risk factors:
Targets for pharmaceutical treatment:
• According to Motivational Interviewing
Other Name: Intensified secondary prevention
- Major vascular event consisting of nonfatal stroke, nonfatal major coronary event and vascular death [ Time Frame: Up to 6 years from inclusion ]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
- Non vascular death [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]
- Other vascular diseases leading to hospital admission (excl. primary outcome measure) [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]Consisting of TIA, Angina pectoris, PAD with vascular intervention
- All hospital admissions with vascular intervention (intraarterial or surgical) [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]
- Bleedings [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]All bleedings leading to therapeutic intervention (categorized according to GUSTO definitions)
- Level of dependency [ Time Frame: Up to 6 years from inclusion ]Assessment according to modified Rankin Score and level of care (German care insurance)
- All hospital admissions [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]
- Days alive and at home [ Time Frame: Participants will be followed-up for an average of approximately 3.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586702
|Dept. of Neurology, Charité Universitätsmedizin Berlin|
|Berlin, Germany, 12200|
|Principal Investigator:||Heinrich J Audebert, MD||Center for Stroke Research, Charité Universitaetsmedizin Berlin|