SITS-IVT in Patients >80 Years Study

Study Overview
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Brief Summary
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A non-interventional post-approval study on Safe Implementation of Treatment in Stroke - International Stroke Thrombolysis Register (SITS-ISTR) existing data of intravenous recombinant tissue plasminogen Activator (rt-PA) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the Summary of Product Characteristics (SmPC) in European countries.

Official Title
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Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study

Conditions
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Ischaemic Stroke

Intervention / Treatment
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* Drug: Alteplase


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Actilyse® (alteplase) pre-approval<br> | Drug: Alteplase<br>* Intravenous injection<br>* Other names: Actilyse®;|
| Actilyse® (alteplase) post-approval<br> | Drug: Alteplase<br>* Intravenous injection<br>* Other names: Actilyse®;|

What is the study measuring?
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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 |  | up to 36 hours | 
| Mortality (mRS=6) within 90 days | 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. | up to 90 days | 
| Functional Independency as defined by mRS 0-2 within 90 days | 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. | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics at baseline including stroke severity (NIHSS) | Baseline measurement during data collection | up to 6 years | 
| Number of Participants with a modified Rankin score (mRS) of 0-1 |  | up to 90 days | 
| Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per European Cooperative Acute Stroke Study 2 (ECASS 2) definition |  | up to 90 days | 
| Delays of management 1: Time from onset of symptoms - start of treatment |  | up to 4.5 hours | 
| Delays of management 2: Time from onset of symptoms - door (or as captured in the registry arrival at hospital) |  | up to 4.5 hours | 
| Delays of management 3: Door - needle time |  | up to 4.5 hours |