N/A
Completed N=1,560
Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
Source: ClinicalTrials.gov NCT05401149 ↗Enrolled (actual)
1,560
Serious AEs
—
Results posted
Oct 2024
Primary outcomePrimary: Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year — 27.7; 23.8 Percentage of Participants — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year |
27.7; 23.8 | <0.001 sig |
| SECONDARY Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation |
13.7; 10.8 | 0.054 |
| SECONDARY All-cause Mortality During Hospitalisation |
4.5; 2.8 | 0.097 |
| SECONDARY Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year |
37.3; 33.7 | <0.001 sig |
| SECONDARY Distribution of Modified Rankin Scale (mRS) Score at 1 Year |
3.5; 3.7 | 0.007 sig |
| SECONDARY All-cause Mortality at 1 Year |
36.2; 31.5 | 0.077 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05401149). 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. Informational only — not medical advice.