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

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.

Study Overview

• Status: Completed
• Conditions: Ischaemic Stroke
• Intervention / Treatment: Drug: Alteplase

• Study Type: Observational
• Enrollment (Actual): 1655

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Actilyse® (alteplase) pre-approval	Drug: Alteplase; Intravenous injection; Other Names: Actilyse®
Actilyse® (alteplase) post-approval	Drug: Alteplase; Intravenous injection; Other Names: Actilyse®

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	Defined as the number of participants presenting intracerebral haemorrhage (parenchymatous haemorrhage type 2, PH2), at the 22-36 hours post-treatment scan or earlier, if clinically indicated, combined with neurological deterioration leading to an increase of 4 points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24h or death within 24 hours (SITS-MOST definition). The NIHSS is a neurological examination tool used to objectively quantify stroke severity. It is composed by 11 items, 3 of which with more than one component, scoring between 0 (normal function) and 2, 3, 7 or 8 (highest degree of impairment) for a specific ability (item). The sum of the individual scores from each item originate the total NIHSS score, where: 0 = no stroke symptoms; 1-4 = minor stroke; 5-15 = moderate stroke; 16-20 = moderate to severe stroke; and 21-42 = severe stroke.	Up to 36 hours after stroke onset, between June 2015 and December 2021
Mortality Within 90 Days, Defined as the Number of Participants With a Death Event	Number of participants who died 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. The International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) was used.	Up to 90 days after stroke onset, between June 2015 and December 2021
Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days	Defined as the number of participants classified with a modified Rankin score (mRS) of 0, 1 or 2 within 90 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The score has a scale from 0 to 6, where: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent and requiring constant nursing care and attention; and 6 = dead.	Up to 90 days after stroke onset, between June 2015 and December 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)	Defined by the total National Institutes of Health Stroke Scale (NIHSS) score presented by the participants of each group at baseline. The NIHSS is a neurological examination tool used to objectively quantify stroke severity. It is composed by 11 items, 3 of which with more than one component, scoring between 0 (normal function) and 2, 3, 7 or 8 (highest degree of impairment) for a specific ability (item). The sum of the individual scores from each item originate the total NIHSS score, where: 0 = no stroke symptoms; 1-4 = minor stroke; 5-15 = moderate stroke; 16-20 = moderate to severe stroke; and 21-42 = severe stroke.	At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021
Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days	Defined as the number of participants achieving of a modified Rankin score (mRS) of 0 or 1 within 90 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The score has a scale from 0 to 6, where: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent and requiring constant nursing care and attention; and 6 = dead.	Up to 90 days after stroke onset, between June 2015 and December 2021
Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition	Defined as the number of participants with any intracerebral haemorrhage including haemorrhagic infarctions at the 22-36 hours post-treatment scan combined with neurological deterioration leading to an increase of 4 points on the National Institutes of Health Stroke Scale (NIHSS) or death within 7 days. The NIHSS is a neurological examination tool used to objectively quantify stroke severity.It is composed by 11 items, 3 of which with more than one component, scoring between 0 (normal function) and 2, 3, 7 or 8 (highest degree of impairment) for a specific ability (item). The sum of the individual scores from each item originate the total NIHSS score, where: 0 = no stroke symptoms; 1-4 = minor stroke; 5-15 = moderate stroke; 16-20 = moderate to severe stroke; and 21-42 = severe stroke.	Up to 7 days after stroke onset, between June 2015 and December 2021
Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment	Time in minutes from the onset of ischaemic stroke symptoms to start of treatment with intravenous thrombolysis with Actilyse® (alteplase).	Up to 4.5 hours after stroke onset, between June 2015 and December 2021
Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital)	Time in minutes from the onset of ischaemic stroke symptoms to hospital door or the registry arrival at the hospital.	Up to 4.5 hours after stroke onset, between June 2015 and December 2021
Door to Needle Time	Time in minutes from hospital door or registry arrival at the hospital to start of treatment with intravenous thrombolysis (IVT) with Actilyse® (alteplase)	Up to 4.5 hours after stroke onset, between June 2015 and December 2021

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: 0135-0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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: No