Clinical trial NCT05395351: Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 113035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.

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).


Eligibility 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

Primary outcomes:
measure: All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
timeFrame: Up to 100 days.
Secondary outcomes:
measure: Percentage of Patients With Hemorrhagic Stroke During Hospitalization
timeFrame: Up to 100 days.
measure: Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
timeFrame: Up to 24 hours.
measure: Modified Rankin Score (mRS) at Discharge
timeFrame: Up to 100 days.
measure: Number of Patients With Stroke Recurrence During Hospitalization
timeFrame: Up to 100 days.
measure: Length of Hospitalization
timeFrame: Up to 100 days.
measure: Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset
timeFrame: Up to 4.5 hours.
measure: Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)
timeFrame: Up to 4.5 hours.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Boehringer Ingelheim (China) Investment Co., ltd.
Study officials:
References: