Clinical trial NCT05401149: Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients
Official title: Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 3058
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, AIS patient data from 80 stroke centres in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from January 2017 to March 2020 will be used.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year
timeFrame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
Secondary outcomes:
measure: Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation
timeFrame: Up to 3 months
measure: All-cause Mortality During Hospitalisation
timeFrame: Up to 3 months
measure: Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year
timeFrame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
measure: Distribution of Modified Rankin Scale (mRS) Score at 1 Year
timeFrame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
measure: All-cause Mortality at 1 Year
timeFrame: Up to 1 year post index hospital admission (between January 2017 and March 2020); data retrieved and studied from July 18, 2022 to December 14, 2022 (approximately 5 months of this study).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Boehringer Ingelheim (China) Investment Co., ltd.
Study officials:
References: