SITS-IVT in Patients >80 Years Study

Ischaemic Stroke Clinical Trial

— SITS_ELDERLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260347
• Other study ID #: 0135-0344
• Status: Completed
• Start date: May 14, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1655
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischaemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Alteplase
Intravenous injection

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) definition		up to 36 hours
Primary	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
Primary	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	Patient characteristics at baseline including stroke severity (NIHSS)	Baseline measurement during data collection	up to 6 years
Secondary	Number of Participants with a modified Rankin score (mRS) of 0-1		up to 90 days
Secondary	Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per European Cooperative Acute Stroke Study 2 (ECASS 2) definition		up to 90 days
Secondary	Delays of management 1: Time from onset of symptoms - start of treatment		up to 4.5 hours
Secondary	Delays of management 2: Time from onset of symptoms - door (or as captured in the registry arrival at hospital)		up to 4.5 hours
Secondary	Delays of management 3: Door - needle time		up to 4.5 hours

External Links

•   Related Info