Clinical trial NCT04260347: SITS-IVT in Patients >80 Years Study
Official title: Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischaemic Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 1655
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 80 years old presenting with acute ischaemic stroke (AIS) symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to the SmPC.

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition
timeFrame: Up to 36 hours after stroke onset, between June 2015 and December 2021
measure: Mortality Within 90 Days, Defined as the Number of Participants With a Death Event
timeFrame: Up to 90 days after stroke onset, between June 2015 and December 2021
measure: Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days
timeFrame: Up to 90 days after stroke onset, between June 2015 and December 2021
Secondary outcomes:
measure: Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)
timeFrame: At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021
measure: Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days
timeFrame: Up to 90 days after stroke onset, between June 2015 and December 2021
measure: Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition
timeFrame: Up to 7 days after stroke onset, between June 2015 and December 2021
measure: Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment
timeFrame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021
measure: Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital)
timeFrame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021
measure: Door to Needle Time
timeFrame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: