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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395351
• Other study ID #: 0135-0348
• Status: Completed
• Start date: November 30, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113035
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• rt-PA
Recombinant Tissue Plasminogen Activator

Locations

Country	Name	City	State
China	Boehringer Ingelheim (China) Investment Co., ltd.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality during hospitalization	analyzed for patients in Group 1 and Group 2	up to 3 months
Secondary	Proportion of patients with hemorrhagic stroke during hospitalization	analyzed for patients in Group 1 and Group 2	up to 3 months
Secondary	Change of National Institutes of Health Stroke Scale (NIHSS) score from before IV rt-PA treatment to 24 hours 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.	baseline and 24 after IV rt-PA treatment
Secondary	modified Rankin Scale (mRS) score at discharge	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.	up to 3 months
Secondary	Proportion of patients with stroke recurrence during hospitalization	analyzed for patients in Group 1 and Group 2	up to 3 months
Secondary	Length of hospitalization	analyzed for patients in Group 1 and Group 2	up to 3 months
Secondary	Percentage of IV rt-PA treatment among AIS patients arrived or were admitted to the hospital within 4.5 hours of symptom onset	The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years).	up to 3 months
Secondary	Percentage of IV rt-PA treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission)	The percentage of IV rt-PA treatment will be calculated based on age groups (18-80 years and >80 years).	up to 3 months

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