SITS-IVT in Patients >80 Years Study (SITS_ELDERLY)

October 13, 2023 updated by: Boehringer Ingelheim

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1655

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Actilyse® (alteplase) pre-approval
Intravenous injection
Other Names:
  • Actilyse®
Actilyse® (alteplase) post-approval
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
Time Frame: up to 36 hours
up to 36 hours
Mortality (mRS=6) within 90 days
Time Frame: up to 90 days
Death 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.
up to 90 days
Functional Independency as defined by mRS 0-2 within 90 days
Time Frame: up to 90 days
A modified Rankin score, mRS, is used to evaluate daily activity of the patient at day 90. The scores are entered in the on-line entry form. The score 0-1 is defined as favourable outcome and 0-2 as independence of the patient.
up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics at baseline including stroke severity (NIHSS)
Time Frame: up to 6 years
Baseline measurement during data collection
up to 6 years
Number of Participants with a modified Rankin score (mRS) of 0-1
Time Frame: up to 90 days
up to 90 days
Number of Participants with Symptomatic intracerebral haemorrhage (SICH) per European Cooperative Acute Stroke Study 2 (ECASS 2) definition
Time Frame: up to 90 days
up to 90 days
Delays of management 1: Time from onset of symptoms - start of treatment
Time Frame: up to 4.5 hours
up to 4.5 hours
Delays of management 2: Time from onset of symptoms - door (or as captured in the registry arrival at hospital)
Time Frame: up to 4.5 hours
up to 4.5 hours
Delays of management 3: Door - needle time
Time Frame: up to 4.5 hours
up to 4.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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