1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

Study Overview
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Brief Summary
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The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

Official Title
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1-year Clinical Outcomes After Intravenous Rt-PA for Chinese AIS Patients

Conditions
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Stroke

Intervention / Treatment
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* Drug: rt-PA


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020 ≥ 18 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IV rt-PA cohort<br>Patients who received IV rt-PA within 4.5 hours of symptom onset | Drug: rt-PA<br>* Recombinant Tissue Plasminogen Activator<br>|
| Non-reperfusion cohort<br>Patients who arrived or were admitted to the hospital within4.5 hours of symptom onset and did not receive any reperfusion treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 1 year (modified Rankin Scale (mRS) score =6) | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS score 0-2 at 1 year |  | up to 1 year | 
| mRS score 0-1 at 1 year |  | up to 1 year | 
| mRS score 5-6 at 1 year |  | up to 1 year | 
| Distribution of mRS score at 1 year |  | up to 1 year |