SITS_ELDERLY: SITS-IVT in Patients >80 Years Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients >80 years after approval
|
Drug: Alteplase
Intravenous injection
Other Names:
|
| Patients >80 years before approval
|
Drug: Alteplase
Intravenous injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [up to 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.
- Functional Independency as defined by mRS 0-2 within 90 days [up to 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.
Secondary Outcome Measures
- Patient characteristics at baseline including stroke severity (NIHSS) [up to 6 years]
Baseline measurement during data collection
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska University Hospital | Stockholm | Sweden | 171 76 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0135-0344