Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IV rt-PA cohort 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
Recombinant Tissue Plasminogen Activator
|
| Non-reperfusion cohort 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 |
Outcome Measures
Primary Outcome Measures
- modified Rankin Scale (mRS) score of 0-1 at 1 year [up to 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.
Secondary Outcome Measures
- 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 [at baseline]
urban employee basic medical insurance, urban resident basic medical insurance, new rural cooperative medical insurance, other insurance, no insurance
- Baseline characteristics: Smoking status [at baseline]
current smoker, former smoker, never smoker
- Baseline characteristics: Stroke severity [at baseline]
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.
- Baseline characteristics: Time from symptom onset to hospital admission [at baseline]
- Baseline characteristics: Time from symptom onset to treatment [at baseline]
for patients in the IV rt-PA cohort
- Baseline characteristics: Time from hospital admission to treatment [at baseline]
for patients in the IV rt-PA cohort
- Baseline characteristics: rt-PA dosage [at baseline]
for patients in the IV rt-PA cohort
- 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]
Eligibility Criteria
Criteria
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
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.- 0135-0349