An observational study in Ischaemic Stroke, sponsored by Boehringer Ingelheim. Completed at 1 site in Sweden. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Boehringer Ingelheim · Observational
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.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's enrollment of 1,655 is above the median of 300 across 787 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Drug: Alteplase
Drug: Alteplase
Intravenous injection
Also known as: Actilyse®
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days after stroke onset, between June 2015 and December 2021
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021
Observational retrospective study based on existing data collected from the Safe Implementation of Treatment in Stroke-International Stroke Treatment Registry (SITS-ISTR) of ischaemic stroke patients older than 80 years of age treated with Actilyse® (alteplase) according to the Summary of Product Characteristics (SmPC) criteria during post-approval and pre-approval periods.
| Milestone | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Started | 993 | 662 |
| Propensity score-matched population | 614 | 614 |
| Completed | 993 | 662 |
| Not completed | 0 | 0 |
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.
| Participants | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition | 14 | 15 |
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.
| Participants | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Mortality Within 90 Days, Defined as the Number of Participants With a Death Event | 161 | 149 |
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.
| Participants | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days | 205 | 233 |
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.
| Units on a scale | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS) | 10.5 (7 to 16) | 11 (6 to 17) |
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.
| Participants | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days | 142 | 158 |
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.
| Participants | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition | 24 | 30 |
Time in minutes from the onset of ischaemic stroke symptoms to start of treatment with intravenous thrombolysis with Actilyse® (alteplase).
| Minutes | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment | 153 (111.25 to 195) | 151 (114.25 to 195) |
Time in minutes from the onset of ischaemic stroke symptoms to hospital door or the registry arrival at the hospital.
| Minutes | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital) | 93 (65 to 135) | 88 (62 to 128) |
Time in minutes from hospital door or registry arrival at the hospital to start of treatment with intravenous thrombolysis (IVT) with Actilyse® (alteplase)
| Minutes | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval |
|---|---|---|
| Door to Needle Time | 46 (27 to 75) | 48 (30 to 79) |
Collected over Adverse event information was not applicable for this study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Actilyse® (Alteplase) Pre-approval | — | — | — |
| Actilyse® (Alteplase) Post-approval | — | — | — |
Propensity score (PS) matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale (mRS) score, baseline National Institute of Health Stroke Scale, systolic blood pressure, glucose level, anti-platelet treatment at stroke onset, hypertension, diabetes, atrial fibrillation, hyperlipidaemia, smoking, previous stroke earlier than 3 months, stroke onset to intravenous thrombolysis treatment start time.
| Age, Continuous(Years) | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval | Total |
|---|---|---|---|
| Mean | 86.6 ± 4.1 | 86.6 ± 4.3 | 86.6 ± 4.2 |
| Sex: Female, Male(Participants) | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval | Total |
|---|---|---|---|
| Female | 377 | 374 | 751 |
| Male | 237 | 240 | 477 |
| Race and Ethnicity Not Collected(Participants) | Actilyse® (Alteplase) Pre-approval | Actilyse® (Alteplase) Post-approval | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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
Ran from May 2020 to primary completion in Dec 2022, 31 months.
Results were first posted in Jul 2024, 1 year 6 months after primary completion.
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