Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1: IV rt-PA cohort with AIS patients aged >80 years AIS patients aged >80 years who received IV rt-PA within 4.5 hours of symptom onset. |
Drug: rt-PA
Recombinant Tissue Plasminogen Activator
|
| Group 2: IV rt-PA cohort with AIS patients aged 18 to 80 years AIS patients aged 18 to 80 years who received IV rt-PA within 4.5 hours of symptom onset. |
Drug: rt-PA
Recombinant Tissue Plasminogen Activator
|
| Group 3: Non-reperfusion cohort with AIS patients aged >80 years 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 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. |
Outcome Measures
Primary Outcome Measures
- All-cause mortality during hospitalization [up to 3 months]
analyzed for patients in Group 1 and Group 2
Secondary Outcome Measures
- Proportion of patients with hemorrhagic stroke during hospitalization [up to 3 months]
analyzed for patients in Group 1 and Group 2
- Change of National Institutes of Health Stroke Scale (NIHSS) score from before IV rt-PA treatment to 24 hours after IV rt-PA treatment [baseline and 24 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.
- modified Rankin Scale (mRS) score at discharge [up to 3 months]
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.
- Proportion of patients with stroke recurrence during hospitalization [up to 3 months]
analyzed for patients in Group 1 and Group 2
- Length of hospitalization [up to 3 months]
analyzed for patients in Group 1 and Group 2
- Percentage of IV rt-PA treatment among AIS patients arrived or were admitted to the hospital within 4.5 hours of symptom onset [up to 3 months]
The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years).
- Percentage of IV rt-PA treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission) [up to 3 months]
The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim (China) Investment Co., ltd. | Shanghai | China | 200040 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0135-0348