Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Boehringer Ingelheim

Status: Completed

Conditions: Stroke

Treatments: Drug: rt-PA

Study type: Observational

Funder types: Industry

Identifiers

NCT05401149

0135-0349

Details and patient eligibility

About

The objective of this study is to find out if Chinese Acute Ischaemic Stroke (AIS) patients older than 80 years benefit from intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) treatment within 4.5 hours of symptom onset in a real-world clinical setting.

Enrollment: 3,058 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020
• > 80 years of age
• Diagnosed with AIS at admission
• Arrived or admitted to the hospital within 4.5 hours of symptom onset
• If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset

Exclusion criteria

• Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC)
• Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale [NIHSS], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment)
• Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
• Received endovascular treatment
• Received IV rt-PA after 4.5 hours of symptom onset

Trial design

3,058 participants in 2 patient groups

IV rt-PA cohort

Description:

Acute Ischaemic Stroke (AIS) patients aged \> 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset

Treatment:

Drug: rt-PA

Non-reperfusion cohort

Description:

Acute Ischaemic Stroke (AIS) patients aged \> 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatments