SITS-IVT in Patients >80 Years Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1655 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-14

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischaemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Actilyse® (alteplase) pre-approval

Alteplase

Intervention Type DRUG

Intravenous injection

Actilyse® (alteplase) post-approval

Alteplase

Intervention Type DRUG

Intravenous injection

Interventions

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Alteplase

Intravenous injection

Intervention Type DRUG

Other Intervention Names

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Actilyse®

Eligibility Criteria

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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.

Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No