SITS-IVT in Patients >80 Years Study
- Registration Number
- NCT04260347
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1655
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Actilyse® (alteplase) pre-approval Alteplase - Actilyse® (alteplase) post-approval Alteplase -
- Primary Outcome Measures
Name Time Method Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition Up to 36 hours after stroke onset, between June 2015 and December 2021 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.
Mortality Within 90 Days, Defined as the Number of Participants With a Death Event Up to 90 days after stroke onset, between June 2015 and December 2021 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.
Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days Up to 90 days after stroke onset, between June 2015 and December 2021 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.
- Secondary Outcome Measures
Name Time Method Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS) At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021 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.
Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days Up to 90 days after stroke onset, between June 2015 and December 2021 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.
Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition Up to 7 days after stroke onset, between June 2015 and December 2021 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.
Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment Up to 4.5 hours after stroke onset, between June 2015 and December 2021 Time in minutes from the onset of ischaemic stroke symptoms to start of treatment with intravenous thrombolysis with Actilyse® (alteplase).
Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital) Up to 4.5 hours after stroke onset, between June 2015 and December 2021 Time in minutes from the onset of ischaemic stroke symptoms to hospital door or the registry arrival at the hospital.
Door to Needle Time Up to 4.5 hours after stroke onset, between June 2015 and December 2021 Time in minutes from hospital door or registry arrival at the hospital to start of treatment with intravenous thrombolysis (IVT) with Actilyse® (alteplase)
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden