Trial Outcomes & Findings for SITS-IVT in Patients >80 Years Study (NCT NCT04260347)
NCT ID: NCT04260347
Last Updated: 2024-07-05
Results Overview
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.
COMPLETED
1655 participants
Up to 36 hours after stroke onset, between June 2015 and December 2021
2024-07-05
Participant Flow
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.
The patients were selected based on the sites fulfilling the criteria defined and treated according to the Summary of Product Characteristics (SmPC) of Actilyse® (alteplase) during pre-approval and post-approval period. The data was collected between June 2015 and December 2021. A patient was excluded from the entire cohort when had missing data on one of the selection steps.
Participant milestones
| Measure |
Actilyse® (Alteplase) Pre-approval
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
993
|
662
|
|
Overall Study
Propensity Score-matched Population
|
614
|
614
|
|
Overall Study
COMPLETED
|
993
|
662
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Actilyse® (Alteplase) Pre-approval
n=614 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=614 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Total
n=1228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
86.6 Years
STANDARD_DEVIATION 4.1 • n=614 Participants
|
86.6 Years
STANDARD_DEVIATION 4.3 • n=614 Participants
|
86.6 Years
STANDARD_DEVIATION 4.2 • n=1228 Participants
|
|
Sex: Female, Male
Female
|
377 Participants
n=614 Participants
|
374 Participants
n=614 Participants
|
751 Participants
n=1228 Participants
|
|
Sex: Female, Male
Male
|
237 Participants
n=614 Participants
|
240 Participants
n=614 Participants
|
477 Participants
n=1228 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 36 hours after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=599 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=603 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition
|
14 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=566 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=589 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
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|---|---|---|
|
Mortality Within 90 Days, Defined as the Number of Participants With a Death Event
|
161 Participants
|
149 Participants
|
PRIMARY outcome
Timeframe: Up to 90 days after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=554 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=578 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days
|
205 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: At baseline, defined as the ischaemic stroke hospital admission date, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=614 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=614 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)
|
10.5 Units on a scale
Interval 7.0 to 16.0
|
11 Units on a scale
Interval 6.0 to 17.0
|
SECONDARY outcome
Timeframe: Up to 90 days after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=554 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=578 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Number of Participants With a Modified Rankin Score (mRS) of 0-1 Within 90 Days
|
142 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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. Participants with missing values were excluded from the analysis of this outcome.
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.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=594 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=603 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per European Cooperative Acute Stroke Study 2 (ECASS 2) Definition
|
24 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Up to 4.5 hours after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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.
Time in minutes from the onset of ischaemic stroke symptoms to start of treatment with intravenous thrombolysis with Actilyse® (alteplase).
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=614 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=614 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Time From Onset of Symptoms to Start of Intravenous Thrombolysis (IVT) Treatment
|
153 Minutes
Interval 111.25 to 195.0
|
151 Minutes
Interval 114.25 to 195.0
|
SECONDARY outcome
Timeframe: Up to 4.5 hours after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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.
Time in minutes from the onset of ischaemic stroke symptoms to hospital door or the registry arrival at the hospital.
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=614 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=614 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Time From Onset of Symptoms to Door (or Captured in the Registry Arrival at the Hospital)
|
93 Minutes
Interval 65.0 to 135.0
|
88 Minutes
Interval 62.0 to 128.0
|
SECONDARY outcome
Timeframe: Up to 4.5 hours after stroke onset, between June 2015 and December 2021Population: Propensity score matched population based on the variables: age, sex, pre-stroke Modified Rankin Scale 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.
Time in minutes from hospital door or registry arrival at the hospital to start of treatment with intravenous thrombolysis (IVT) with Actilyse® (alteplase)
Outcome measures
| Measure |
Actilyse® (Alteplase) Pre-approval
n=614 Participants
Patients older than 80 years presenting acute ischaemic stroke symptoms, between June 2015 and July 2018 (or the exact approval date), received once intravenous thrombolysis treatment with off-label Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
Actilyse® (Alteplase) Post-approval
n=614 Participants
Patients older than 80 years old presenting acute ischaemic stroke symptoms, between 1st July 2018 (or the first day of the next month after exact approval date) to December 2021, received once intravenous thrombolysis treatment with Actilyse® (alteplase) within 4.5 hours after stroke onset, according to the Summary of Product Characteristics (SmPC). The recommended total dose was 0.9 milligrams (mg) alteplase per kilogram body weight (maximum of 90 mg) starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
|
|---|---|---|
|
Door to Needle Time
|
46 Minutes
Interval 27.0 to 75.0
|
48 Minutes
Interval 30.0 to 79.0
|
Adverse Events
Actilyse® (Alteplase) Pre-approval
Actilyse® (Alteplase) Post-approval
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER