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

Completed

• Conditions: Stroke
• Interventions: Drug: rt-PA

• Registration Number: NCT05395351
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-27
• Study Start: 2022-11-30
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Results First Submitted: 2024-03-21
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Results First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113035

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke (AIS) patients aged >80 years who received IV rt-PA (Alteplase)	rt-PA	Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
Acute ischemic stroke (AIS) patients aged 18 to 80 years who received IV rt-PA (Alteplase)	rt-PA	Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.

Primary Outcome Measures

Name	Time	Method
All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients	Up to 100 days.	All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Hemorrhagic Stroke During Hospitalization	Up to 100 days.	Percentage of patients with hemorrhagic stroke during hospitalization.
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment	Up to 24 hours.	The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.
Modified Rankin Score (mRS) at Discharge	Up to 100 days.	The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
Number of Patients With Stroke Recurrence During Hospitalization	Up to 100 days.	Number of patients with stroke recurrence during hospitalization.
Length of Hospitalization	Up to 100 days.	Length of hospitalization.
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	Up to 4.5 hours.	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.
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)	Up to 4.5 hours.	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).

Trial Locations

Locations (1)

Boehringer Ingelheim (China) Investment Co., ltd.; 🇨🇳 Shanghai, China