N/A
N=113,035
Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05395351 ↗Enrolled (actual)
113,035
Serious AEs
—
Results posted
Dec 2024
Primary outcome: Primary: All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients — 2.6; 0.8 Percentage of participants
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
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients |
2.6; 0.8 | — |
| SECONDARY Percentage of Patients With Hemorrhagic Stroke During Hospitalization |
6.7; 3.1 | — |
| SECONDARY Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment |
2.8; 2.5 | — |
| SECONDARY Modified Rankin Score (mRS) at Discharge |
383; 5447; 612; 6427; 281; 2131 | — |
| SECONDARY Number of Patients With Stroke Recurrence During Hospitalization |
369; 2039 | — |
| SECONDARY Length of Hospitalization |
12.7; 11.5 | — |
| SECONDARY Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset |
21.0; 28.9 | — |
| SECONDARY Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission) |
23.9; 32.2 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05395351). 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.