Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization

Study Overview
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Brief Summary
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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).

Official Title
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Characteristics and In-hospital Outcomes of Chinese Elderly (>80 Years) Patients With Acute Ischemic Stroke Receiving Intravenous Recombinant Tissue Plasminogen Activator Treatment Within 4.5 Hours of Symptom Onset

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: 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

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 |
| --- | --- |
| Group 1: IV rt-PA cohort with AIS patients aged >80 years<br>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>|
| Group 2: IV rt-PA cohort with AIS patients aged 18 to 80 years<br>AIS patients aged 18 to 80 years who received IV rt-PA within 4.5 hours of symptom onset. | Drug: rt-PA<br>* Recombinant Tissue Plasminogen Activator<br>|
| Group 3: Non-reperfusion cohort with AIS patients aged >80 years<br>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. | |
| Group 4: Non-reperfusion cohort with AIS patients aged 18 to 80 years<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality during hospitalization | analyzed for patients in Group 1 and Group 2 | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with hemorrhagic stroke during hospitalization | analyzed for patients in Group 1 and Group 2 | up to 3 months | 
| Change of National Institutes of Health Stroke Scale (NIHSS) score from before IV rt-PA treatment to 24 hours after IV rt-PA treatment | analyzed for patients in Group 1 and Group 2 The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. | baseline and 24 after IV rt-PA treatment | 
| modified Rankin Scale (mRS) score at discharge | analyzed for patients in Group 1 and Group 2 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 3 months | 
| Proportion of patients with stroke recurrence during hospitalization | analyzed for patients in Group 1 and Group 2 | up to 3 months | 
| Length of hospitalization | analyzed for patients in Group 1 and Group 2 | up to 3 months | 
| Percentage of IV rt-PA treatment among AIS patients arrived or were admitted to the hospital within 4.5 hours of symptom onset | The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years). | up to 3 months | 
| Percentage of IV rt-PA treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission) | The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years). | up to 3 months |