Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization

Boehringer Ingelheim

Status: Completed

Conditions: Stroke

Treatments: Drug: rt-PA

Study type: Observational

Funder types: Industry

Identifiers

NCT05395351

0135-0348

Details and patient eligibility

About

The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).

Enrollment: 113,035 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019
• ≥18 years old
• Diagnosed as Acute Ischemic Stroke (AIS) at admission
• Arrived or admitted into hospital within 4.5 hours of symptom onset
• For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset

Exclusion criteria

• Documented Intravenous Thrombolysis (IVT) absolute contraindication
• Key data missing (age, gender, baseline National Institutes of Health Stroke Scale [NIHSS], time of symptom onset, IVT treated or not, time of IV alteplase treatment)
• Received thrombolysis agents other than IV 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

113,035 participants in 4 patient groups

Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)

Description:

Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.

Treatment:

Drug: rt-PA

Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)

Description:

Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.

Treatment:

Drug: rt-PA

Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment

Description:

Group 3: Acute ischemic 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 thrombolysis treatment.

Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment

Description:

Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.