Ischaemic StrokeSITS_ELDERLYNCT04260347

SITS-IVT in Patients >80 Years Study

An observational study of Ischaemic Stroke, run by Boehringer Ingelheim at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 80 years and older
Conditions the study is for: Ischaemic Stroke
What is being tested?: Alteplase
Type of treatment: Injection or infusion
How many people: 1,655 participants
Where: 1 siteSweden
Study dates: 14 May 2020to 31 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 80 years and older
All sexes
No healthy volunteers
Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska University Hospital
Stockholm, 171 76

Other trials in Sweden

About this study

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

Conditions: Ischaemic Stroke
Being tested: Alteplase
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlteplaseDrug
Also called Actilyse®
Intravenous injection

Study groups in NCT04260347
Study group	Role	What they receive
Actilyse® (alteplase) pre-approval		Not described Receives: Drug: Alteplase
Actilyse® (alteplase) post-approval		Not described Receives: Drug: Alteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Up to 90 days after stroke onset, between June 2015 and December 2021

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Up to 4.5 hours after stroke onset, between June 2015 and December 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 202031 Dec 2022

First posted7 Feb 2020
Study start14 May 2020
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,655 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04260347
Sponsor's protocol ID: 0135-0344
Acronym: SITS_ELDERLY
Status last verified: Jul 2024
First submitted: 31 Jan 2020
Last updated: 5 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
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All Ischaemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safe Implementation of Treatments in Stroke (SITS) - Intravenous Thrombolysis in Acute Ischaemic Stroke Patients Over 80 Years, SITS-IVT>80 Years Study
ClinicalTrials.gov ID: NCT04260347
Acronym / sponsor ID: SITS_ELDERLY / 0135-0344
Conditions: Ischaemic Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 1,655 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 14 May 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 7 Feb 2020 (actual)
Results: Posted 5 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Actilyse® (alteplase) pre-approval	–	Drug: Alteplase
Actilyse® (alteplase) post-approval	–	Drug: Alteplase

Who may qualify

Ages: 80 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlteplaseAlso: Actilyse®Intravenous injection	Drug	Actilyse® (alteplase) post-approval, Actilyse® (alteplase) pre-approval

Primary outcome

Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition
Time frame: 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
Time frame: 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
Time frame: 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.

6 secondary outcomes

Stroke Severity, Defined by the National Institute of Health's Stroke Scale (NIHSS)
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
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
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 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 frame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021
Door to Needle Time
Time frame: Up to 4.5 hours after stroke onset, between June 2015 and December 2021

Results and safety

Results posted to the registry on 5 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Actilyse® (Alteplase) Pre-approval	993	993
Actilyse® (Alteplase) Post-approval	662	662

Primary outcome: Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition

Time frame: Up to 36 hours after stroke onset, between June 2015 and December 2021. Count of participants. Unit: Participants

Measure	Actilyse® (Alteplase) Pre-approval n = 599	Actilyse® (Alteplase) Post-approval n = 603
Value	14	15

Actilyse® (Alteplase) Pre-approval vs Actilyse® (Alteplase) Post-approval: Risk Ratio (RR): 1.064 (95% CI 0.345 to 1.784), p = 1.000, Chi-squared

Population analysed: 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.

Primary outcome: Mortality Within 90 Days, Defined as the Number of Participants With a Death Event

Time frame: Up to 90 days after stroke onset, between June 2015 and December 2021. Count of participants. Unit: Participants

Measure	Actilyse® (Alteplase) Pre-approval n = 566	Actilyse® (Alteplase) Post-approval n = 589
Value	161	149

Actilyse® (Alteplase) Pre-approval vs Actilyse® (Alteplase) Post-approval: Risk Ratio (RR): 0.889 (95% CI 0.699 to 1.08), p = 0.254, Chi-squared

Primary outcome: Functional Independency, as Defined by a mRS (Modified Rankin Score) 0-2 Within 90 Days

Time frame: Up to 90 days after stroke onset, between June 2015 and December 2021. Count of participants. Unit: Participants

Measure	Actilyse® (Alteplase) Pre-approval n = 554	Actilyse® (Alteplase) Post-approval n = 578
Value	205	233

Actilyse® (Alteplase) Pre-approval vs Actilyse® (Alteplase) Post-approval: Risk Ratio (RR): 1.089 (95% CI 0.942 to 1.237), p = 0.280, Chi-squared

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Actilyse® (Alteplase) Pre-approval	0 of 0	0 of 0	0
Actilyse® (Alteplase) Post-approval	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Ischaemic Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischaemic Stroke, run by Boehringer Ingelheim at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Symptomatic Intracerebral Haemorrhage (SICH) Per Safe Implementation of Thrombolysis - Stroke-Monitoring Study (SITS-MOST) Definition (time frame: Up to 36 hours after stroke onset, between June 2015 and December 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.