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

Boehringer Ingelheim

Status

Completed

Conditions

Ischaemic Stroke

Treatments

Drug: Alteplase

Study type

Observational

Funder types

Industry

Identifiers

NCT04260347

0135-0344

Details and patient eligibility

About

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.

Enrollment

1,655 patients

Sex

All

Ages

80+ years old

Volunteers

No Healthy Volunteers

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.