Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
NCT ID: NCT05395351
Last Updated: 2024-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
113035 participants
OBSERVATIONAL
2022-11-30
2023-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)
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.
rt-PA
Intravenous recombinant tissue plasminogen activator (IV rt-PA)
Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)
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.
rt-PA
Intravenous recombinant tissue plasminogen activator (IV rt-PA)
Acute ischemic stroke (AIS) patients aged >80 years without thrombolysis treatment
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.
No interventions assigned to this group
Acute ischemic stroke (AIS) patients aged 18 to 80 years without thrombolysis treatment
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.
No interventions assigned to this group
Interventions
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rt-PA
Intravenous recombinant tissue plasminogen activator (IV rt-PA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Boehringer Ingelheim (China) Investment Co., ltd.
Shanghai, , China
Countries
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References
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Jiang Y, Wang C, Gu H, Zhou Q, Jiang Y, Li Z, Wang Y. In-hospital outcomes of intravenous recombinant tissue plasminogen activator treatment for acute ischemic stroke in patients aged >80 years: Findings from the Chinese Stroke Center Alliance. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108102. doi: 10.1016/j.jstrokecerebrovasdis.2024.108102. Epub 2024 Oct 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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0135-0348
Identifier Type: -
Identifier Source: org_study_id