Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

NCT ID: NCT05401149

Last Updated: 2024-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3058 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-18

Study Completion Date

2022-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IV rt-PA cohort

Acute Ischaemic Stroke (AIS) patients aged \> 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset

rt-PA

Intervention Type DRUG

Recombinant Tissue Plasminogen Activator

Non-reperfusion cohort

Acute Ischaemic 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 any reperfusion treatments

No interventions assigned to this group

Interventions

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rt-PA

Recombinant Tissue Plasminogen Activator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boehringer Ingelheim (China) Investment Co., ltd.

Shanghai, , China

Site Status

Countries

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China

References

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Yang J, Huang YH, Zhong W, Gong X, Chen Y, Chen Z, Jin H, Yan S, Huang L, Yuan CZ, Lou M. Effectiveness of intravenous recombinant plasminogen activator treatment in Chinese patients with acute ischaemic stroke aged over 80 years: a retrospective cohort study. Stroke Vasc Neurol. 2025 Apr 30:svn-2024-004004. doi: 10.1136/svn-2024-004004. Online ahead of print.

Reference Type DERIVED
PMID: 40312065 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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0135-0349

Identifier Type: -

Identifier Source: org_study_id

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