1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

Boehringer Ingelheim

Status

Completed

Conditions

Stroke

Treatments

Drug: rt-PA

Study type

Observational

Funder types

Industry

Identifiers

NCT05395338

0135-0350

Details and patient eligibility

About

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

Enrollment

12,551 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020
≥ 18 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