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Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

Effectiveness and Safety of IV Rt-PA Treatment in Chinese AIS Patients Aged Above 80 Years: a Real-world Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05401149
Enrollment
3058
Registered
2022-06-02
Start date
2022-07-18
Completion date
2022-12-14
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DRUGrt-PA

Recombinant Tissue Plasminogen Activator

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Percentage of Patients With Any Intracranial Haemorrhage (ICH) During HospitalisationUp to 3 monthsPercentage 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 HospitalisationUp to 3 monthsAll-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 YearUp 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 YearUp 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 YearUp 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.

Countries

China

Participant flow

Recruitment details

This non-interventional study (NIS) based on existing data collected from the Zhejiang Stroke Quality Control Centre (ZSQCC) platform of Acute Ischaemic Stroke (AIS) to compare the 1-year favourable neurological functional outcome of Chinese AIS patients aged \> 80 years who received intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) treatment within 4.5 hours of symptom onset versus those who did not receive reperfusion therapy within 4.5 hours of symptom onset.

Pre-assignment details

98,330 AIS patients were registered in the ZSQCC platform from January 2017 to March 2020. Based on the protocol screening criteria, a total of 3058 patients were included in the final analysis. Then, the study cohorts (patients who received IV rt-PA and patients who did not receive reperfusion treatment) were matched 1:1 by baseline characteristics using the propensity score matching (PSM) method. Propensity score matched patients are 1560 patients.

Participants by arm

ArmCount
IV Rt-PA Cohort
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
780
Non-reperfusion Cohort
Acute Ischaemic Stroke (AIS) patients aged \> 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatments
780
Total1,560

Baseline characteristics

CharacteristicIV Rt-PA CohortNon-reperfusion CohortTotal
Age, Continuous85.2 Years
STANDARD_DEVIATION 3.4
85.3 Years
STANDARD_DEVIATION 3.7
85.2 Years
STANDARD_DEVIATION 3.6
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
413 Participants396 Participants809 Participants
Sex: Female, Male
Male
367 Participants384 Participants751 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
308 / 780303 / 780
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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).

Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1), clinical outcomes and baseline characteristics were compared between the matched cohorts. Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

ArmMeasureValue (NUMBER)
IV Rt-PA CohortPercentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year27.7 Percentage of Participants
Non-reperfusion CohortPercentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year23.8 Percentage of Participants
p-value: <0.00195% CI: [1.35, 2.59]Regression, Logistic
Secondary

All-cause Mortality at 1 Year

All-cause mortality at 1 year.

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).

Population: Among PSM cohort (1560 patients), 120 patients (41 in IV rt-PA group; 79 in non-reperfusion therapy group) were excluded from the analysis due to missing date of death.~To ensure that each matching pair has one patient from IV rt-PA group and one patient from non-reperfusion therapy group at the same time further 118 patients (78 in IV rt-PA group; 40 in non-reperfusion therapy group) were excluded.

ArmMeasureValue (NUMBER)
IV Rt-PA CohortAll-cause Mortality at 1 Year36.2 Percentage of Participants
Non-reperfusion CohortAll-cause Mortality at 1 Year31.5 Percentage of Participants
p-value: 0.07795% CI: [0.98, 1.64]Regression, Cox
Secondary

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

Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

ArmMeasureValue (NUMBER)
IV Rt-PA CohortAll-cause Mortality During Hospitalisation4.5 Percentage of Participants
Non-reperfusion CohortAll-cause Mortality During Hospitalisation2.8 Percentage of Participants
p-value: 0.09795% CI: [0.88, 4.86]Regression, Logistic
Secondary

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.

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).

Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

ArmMeasureValue (MEAN)Dispersion
IV Rt-PA CohortDistribution of Modified Rankin Scale (mRS) Score at 1 Year3.5 Units on a scaleStandard Deviation 2.4
Non-reperfusion CohortDistribution of Modified Rankin Scale (mRS) Score at 1 Year3.7 Units on a scaleStandard Deviation 2.3
p-value: 0.00795% CI: [0.64, 0.93]Regression, Logistic
Secondary

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

Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

ArmMeasureValue (NUMBER)
IV Rt-PA CohortPercentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation13.7 Percentage of Participants
Non-reperfusion CohortPercentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation10.8 Percentage of Participants
p-value: 0.05495% CI: [0.99, 2.06]Regression, Logistic
Secondary

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

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.

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).

Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>80 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.

ArmMeasureValue (NUMBER)
IV Rt-PA CohortPercentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year37.3 Percentage of Participants
Non-reperfusion CohortPercentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year33.7 Percentage of Participants
p-value: <0.00195% CI: [1.48, 2.75]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026