1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients

Completed

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

• Registration Number: NCT05395338
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-27
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Results First Submitted: 2023-11-28
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12551

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IV rt-PA cohort	rt-PA	Patients who received IV rt-PA within 4.5 hours of symptom onset

Primary Outcome Measures

Name	Time	Method
All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)	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.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Functional Independence (mRS Score 0 to 2) 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.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
Percentage of Patients With Favourable Outcome (mRS Score 0 to 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.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
Percentage of Patients With mRS Score 5 to 6 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.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.
Distribution of mRS Score 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. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components.; The scale runs from 0-6, from 'perfect health without symptoms' to 'death'.

Trial Locations

Locations (1)

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