N/A N=12,551

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

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT05395338 ↗

Enrolled (actual)

12,551

Serious AEs

—

Results posted

Oct 2024

Primary outcome: Primary: All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) — 11.1; 12.2 Percentage of Participants — p=0.183

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: rt-PA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)	11.1; 12.2	0.183
SECONDARY Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year	70.9; 66.4	<0.001 sig
SECONDARY Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year	59.5; 54.6	<0.001 sig
SECONDARY Percentage of Patients With mRS Score 5 to 6 at 1 Year	15.9; 20.3	<0.001 sig
SECONDARY Distribution of mRS Score at 1 Year	1.8; 2.0	<0.001 sig

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05395338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.