Trial Outcomes & Findings for Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients (NCT NCT05401149)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3058 participants

Primary outcome timeframe

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).

Results posted on

2024-10-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	780	780
Overall Study COMPLETED	780	780
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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	Total n=1560 Participants Total of all reporting groups
Age, Continuous	85.2 Years STANDARD_DEVIATION 3.4 • n=780 Participants	85.3 Years STANDARD_DEVIATION 3.7 • n=780 Participants	85.2 Years STANDARD_DEVIATION 3.6 • n=1560 Participants
Sex: Female, Male Female	413 Participants n=780 Participants	396 Participants n=780 Participants	809 Participants n=1560 Participants
Sex: Female, Male Male	367 Participants n=780 Participants	384 Participants n=780 Participants	751 Participants n=1560 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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
Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year	27.7 Percentage of Participants Interval 24.6 to 30.8	23.8 Percentage of Participants Interval 20.9 to 26.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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
Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation	13.7 Percentage of Participants Interval 11.3 to 16.1	10.8 Percentage of Participants Interval 8.6 to 12.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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
All-cause Mortality During Hospitalisation	4.5 Percentage of Participants Interval 3.0 to 5.9	2.8 Percentage of Participants Interval 1.7 to 4.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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
Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year	37.3 Percentage of Participants Interval 33.9 to 40.7	33.7 Percentage of Participants Interval 30.4 to 37.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=780 Participants 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	Non-reperfusion Cohort n=780 Participants 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
Distribution of Modified Rankin Scale (mRS) Score at 1 Year	3.5 Units on a scale Standard Deviation 2.4	3.7 Units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

All-cause mortality at 1 year.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=661 Participants 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	Non-reperfusion Cohort n=661 Participants 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
All-cause Mortality at 1 Year	36.2 Percentage of Participants Interval 32.5 to 39.8	31.5 Percentage of Participants Interval 27.9 to 35.0

Adverse Events

IV Rt-PA Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 308 deaths

Non-reperfusion Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 303 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER