Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Study Overview
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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.

Official Title
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Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study

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 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

Ages Eligible for Study
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Minimum Age: 80 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>Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) cohort: AIS patients aged > 80 years 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>Non-reperfusion cohort: AIS patients aged > 80 years who arrived or admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatments | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) score of 0-1 at 1 year | 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 |
| --- | --- | --- |
| Intracranial haemorrhage (ICH) during hospitalisation |  | up to 3 months | 
| All-cause mortality during hospitalisation |  | up to 3 months | 
| mRS score of 0-2 at 1 year |  | up to 1 year | 
| Distribution of mRS score at 1 year |  | up to 1 year | 
| All-cause mortality at 1 year |  | up to 1 year | 
| Baseline characteristics: Age |  | at baseline | 
| Baseline characteristics: Gender |  | at baseline | 
| Baseline characteristics: Body weight |  | at baseline | 
| Baseline characteristics: Medical insurance status | urban employee basic medical insurance, urban resident basic medical insurance, new rural cooperative medical insurance, other insurance, no insurance | at baseline | 
| Baseline characteristics: Smoking status | current smoker, former smoker, never smoker | at baseline | 
| Baseline characteristics: Stroke severity | Stroke severity is measured via the National Institutes of Health Stroke Scale (NIHSS). The NIHSS score ranges from 0 to 42. Higher scores indicate more severe neurological impairment. | at baseline | 
| Baseline characteristics: Time from symptom onset to hospital admission |  | at baseline | 
| Baseline characteristics: Time from symptom onset to treatment | for patients in the IV rt-PA cohort | at baseline | 
| Baseline characteristics: Time from hospital admission to treatment | for patients in the IV rt-PA cohort | at baseline | 
| Baseline characteristics: rt-PA dosage | for patients in the IV rt-PA cohort | at baseline | 
| Baseline characteristics: Number of subjects with Comorbidities |  | at baseline | 
| Baseline characteristics: Number of subjects with Co-medication |  | at baseline | 
| Baseline characteristics: Hospital level (grade 2 or 3) |  | at baseline |