Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Completed

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

• Registration Number: NCT05401149
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-02
• Study Start: 2022-07-18
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Results First Submitted: 2023-12-12
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-10-17
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3058

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	Acute Ischaemic Stroke (AIS) patients aged \> 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) (Alteplase) within 4.5 hours of symptom onset

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year	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).	Percentage of patients with favourable outcome (modified Rankin Scale (mRS) 0-1) at 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.; 2. - Slight disability.; 3. - Moderate disability.; 4. - Moderately severe disability.; 5. - Severe disability.; 6. - Dead.; Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation	Up to 3 months	Percentage of patients with any intracranial haemorrhage (ICH) during hospitalisation.; Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.
All-cause Mortality During Hospitalisation	Up to 3 months	All-cause mortality during hospitalisation.; Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.
Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year	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).	Percentage of patients with independence (modified Rankin Scale (mRS) 0-2) at 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.; 2. - Slight disability.; 3. - Moderate disability.; 4. - Moderately severe disability.; 5. - Severe disability.; 6. - Dead.; Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.
Distribution of Modified Rankin Scale (mRS) Score at 1 Year	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).	Distribution of modified Rankin Scale (mRS) score at 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.; 2. - Slight disability.; 3. - Moderate disability.; 4. - Moderately severe disability.; 5. - Severe disability.; 6. - Dead.; Reported percentages of subjects were calculated from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.
All-cause Mortality at 1 Year	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).	All-cause mortality at 1 year.

Trial Locations

Locations (1)

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