N/A
N=1,560
Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05401149 ↗Enrolled (actual)
1,560
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- rt-PA (Drug)
- Age
- Older Adult · 80+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2022
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 |
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.
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.