Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Boehringer Ingelheim3,058 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,058

Conditions

Stroke

Interventions

rt-PADRUG

Recombinant Tissue Plasminogen Activator

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: * Patients registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020 * \> 80 years of age * Diagnosed with AIS at admission * Arrived or admitted to the hospital within 4.5 hours of symptom onset * If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset Exclusion criteria: * Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC) * Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment) * Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase) * Received endovascular treatment * Received IV rt-PA after 4.5 hours of symptom onset

Locations (1)

Boehringer Ingelheim (China) Investment Co., ltd.

Shanghai, China

Outcomes

Primary Outcomes

Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year

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.

Time frame: 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).

Secondary Outcomes

Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation

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.

Time frame: Up to 3 months

All-cause Mortality During Hospitalisation

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.

Time frame: Up to 3 months

Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year

Data from ClinicalTrials.gov

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Distribution of Modified Rankin Scale (mRS) Score at 1 Year

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.