- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04260347
SITS-IVT in Patients >80 Years Study (SITS_ELDERLY)
Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholm, Sweden, 171 76
- Karolinska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over 80 years old presenting with acute ischaemic stroke symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to SmPC are included.
- Patients over 80 years who received thrombolysis according to SmPC for acute ischaemic stroke (AIS) within 4.5 hours after stroke onset during the period (approximately 3 years) prior to July 2018 are included.
Exclusion Criteria:
- Contraindication(s) to the use of IV thrombolysis per local SmPC.
- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of index event and for the duration of the data collection.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Actilyse® (alteplase) pre-approval
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Intravenous injection
Other Names:
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Actilyse® (alteplase) post-approval
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Intravenous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) definition
Time Frame: up to 36 hours
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up to 36 hours
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Mortality (mRS=6) within 90 days
Time Frame: up to 90 days
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Death within 90 days as classified by the investigator according to cause: cerebral infarct, cerebral haemorrhage, cerebral infarct and haemorrhage unspecified, myocardial infarct, pulmonary embolism, pneumonia, other vascular cause, unknown and other cause of death.
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up to 90 days
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Functional Independency as defined by mRS 0-2 within 90 days
Time Frame: up to 90 days
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A modified Rankin score, mRS, is used to evaluate daily activity of the patient at day 90.
The scores are entered in the on-line entry form.
The score 0-1 is defined as favourable outcome and 0-2 as independence of the patient.
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up to 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient characteristics at baseline including stroke severity (NIHSS)
Time Frame: up to 6 years
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Baseline measurement during data collection
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up to 6 years
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Number of Participants with a modified Rankin score (mRS) of 0-1
Time Frame: up to 90 days
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up to 90 days
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Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per European Cooperative Acute Stroke Study 2 (ECASS 2) definition
Time Frame: up to 90 days
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up to 90 days
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Delays of management 1: Time from onset of symptoms - start of treatment
Time Frame: up to 4.5 hours
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up to 4.5 hours
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Delays of management 2: Time from onset of symptoms - door (or as captured in the registry arrival at hospital)
Time Frame: up to 4.5 hours
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up to 4.5 hours
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Delays of management 3: Door - needle time
Time Frame: up to 4.5 hours
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up to 4.5 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0135-0344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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