Trial Outcomes & Findings for Alteplase in Elderly Acute Ischemic Stroke (AIS) Patients During Hospitalization (NCT NCT05395351)
NCT ID: NCT05395351
Last Updated: 2024-12-20
Results Overview
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
COMPLETED
113035 participants
Up to 100 days.
2024-12-20
Participant Flow
In this study the Chinese Stroke Centre Alliance (CSCA) data was used to describe the in-hospital clinical outcomes regarding safety and effectiveness for acute ischemic stroke (AIS) patients who were treated with intravenous recombinant tissue plasminogen activator (IV rt-PA) within 4.5 hours of symptom onset, aged above 80 years, as well as between 18 and 80 years.
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment
Group 3: Acute ischemic 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 thrombolysis treatment.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment
Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3332
|
28086
|
12533
|
69084
|
|
Overall Study
COMPLETED
|
3332
|
28086
|
12533
|
69084
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=3332 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=28086 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment
n=12533 Participants
Group 3: Acute ischemic 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 thrombolysis treatment.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment
n=69084 Participants
Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.
|
Total
n=113035 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
84.4 years
STANDARD_DEVIATION 3.2 • n=3332 Participants
|
63.2 years
STANDARD_DEVIATION 10.7 • n=28086 Participants
|
84.9 years
STANDARD_DEVIATION 3.4 • n=12533 Participants
|
64.2 years
STANDARD_DEVIATION 10.4 • n=69084 Participants
|
66.8 years
STANDARD_DEVIATION 12.2 • n=113035 Participants
|
|
Sex: Female, Male
Female
|
1710 Participants
n=3332 Participants
|
9188 Participants
n=28086 Participants
|
6418 Participants
n=12533 Participants
|
24409 Participants
n=69084 Participants
|
41725 Participants
n=113035 Participants
|
|
Sex: Female, Male
Male
|
1622 Participants
n=3332 Participants
|
18898 Participants
n=28086 Participants
|
6115 Participants
n=12533 Participants
|
44675 Participants
n=69084 Participants
|
71310 Participants
n=113035 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 100 days.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase). Endpoint was planned to only include Group 1 and 2.
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=3332 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=28086 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
|
2.6 Percentage of participants
Interval 2.1 to 3.2
|
0.8 Percentage of participants
Interval 0.7 to 0.9
|
SECONDARY outcome
Timeframe: Up to 100 days.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.
Percentage of patients with hemorrhagic stroke during hospitalization.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=3332 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=28086 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Percentage of Patients With Hemorrhagic Stroke During Hospitalization
|
6.7 Percentage of subjects
Interval 5.8 to 7.5
|
3.1 Percentage of subjects
Interval 2.9 to 3.3
|
SECONDARY outcome
Timeframe: Up to 24 hours.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2. Only patients with collected NIHSS scores were included in the endpoint.
The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=1404 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=10652 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
|
2.8 Score on a scale
Standard Deviation 5.0
|
2.5 Score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Up to 100 days.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Subjects without a discharge mRS score were excluded. Endpoint was planned to only include Group 1 and 2.
The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=2325 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=18674 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Modified Rankin Score (mRS) at Discharge
mRS score 0
|
383 Participants
|
5447 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 1
|
612 Participants
|
6427 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 2
|
281 Participants
|
2131 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 3
|
216 Participants
|
1393 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 4
|
399 Participants
|
2163 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 5
|
346 Participants
|
902 Participants
|
|
Modified Rankin Score (mRS) at Discharge
mRS score 6
|
88 Participants
|
211 Participants
|
SECONDARY outcome
Timeframe: Up to 100 days.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.
Number of patients with stroke recurrence during hospitalization.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=3332 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=28086 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Number of Patients With Stroke Recurrence During Hospitalization
|
369 Participants
|
2039 Participants
|
SECONDARY outcome
Timeframe: Up to 100 days.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission. Endpoint was planned to only include Group 1 and 2.
Length of hospitalization.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=3318 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=27952 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Length of Hospitalization
|
12.7 days
Standard Deviation 9.6
|
11.5 days
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Up to 4.5 hours.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission.
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=15865 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=97170 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset
|
21.0 Percentage of participants
Interval 20.4 to 21.6
|
28.9 Percentage of participants
Interval 28.6 to 29.2
|
SECONDARY outcome
Timeframe: Up to 4.5 hours.Population: Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission and who arrived to the hospital within 3.5 hours of symptom onset and who were eligible for rt-PA treatment.
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).
Outcome measures
| Measure |
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
n=13639 Participants
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
n=84982 Participants
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
|
|---|---|---|
|
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)
|
23.9 Percentage of participants
Interval 23.2 to 24.6
|
32.2 Percentage of participants
Interval 31.8 to 32.5
|
Adverse Events
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase)
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase)
Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment
Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place