Stroke
Conditions
Brief summary
The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).
Interventions
DRUGrt-PA
Intravenous recombinant tissue plasminogen activator (IV rt-PA)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient registered in the Chinese Stroke Centre Alliance (CSCA) platform from Aug 2015 to Jul 2019 * ≥18 years old * Diagnosed as Acute Ischemic Stroke (AIS) at admission * Arrived or admitted into hospital within 4.5 hours of symptom onset * For patients in the iv rt-PA groups only: received IV rt-PA within 4.5 hours of symptom onset
Exclusion criteria
* Documented Intravenous Thrombolysis (IVT) absolute contraindication * Key data missing (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, IVT treated or not, time of IV alteplase treatment) * Received thrombolysis agents other than IV 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | Up to 100 days. | All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | Up to 24 hours. | 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. |
| Modified Rankin Score (mRS) at Discharge | Up to 100 days. | 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. |
| Number of Patients With Stroke Recurrence During Hospitalization | Up to 100 days. | Number of patients with stroke recurrence during hospitalization. |
| Percentage of Patients With Hemorrhagic Stroke During Hospitalization | Up to 100 days. | Percentage of patients with hemorrhagic stroke during hospitalization. |
| 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 | Up to 4.5 hours. | 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. |
| 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) | Up to 4.5 hours. | 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). |
| Length of Hospitalization | Up to 100 days. | Length of hospitalization. |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3,332 |
| 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. | 28,086 |
| 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. | 12,533 |
| 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. | 69,084 |
| Total | 113,035 |
Baseline characteristics
| Characteristic | 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 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 84.4 years STANDARD_DEVIATION 3.2 | 63.2 years STANDARD_DEVIATION 10.7 | 84.9 years STANDARD_DEVIATION 3.4 | 64.2 years STANDARD_DEVIATION 10.4 | 66.8 years STANDARD_DEVIATION 12.2 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1710 Participants | 9188 Participants | 6418 Participants | 24409 Participants | 41725 Participants |
| Sex: Female, Male Male | 1622 Participants | 18898 Participants | 6115 Participants | 44675 Participants | 71310 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 88 / 3,332 | 211 / 28,086 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | 2.6 Percentage of participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | 0.8 Percentage of participants |
Secondary
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 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 |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | 2.5 Score on a scale | Standard Deviation 4.3 |
Secondary
Length of Hospitalization
Length of hospitalization.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Length of Hospitalization | 12.7 days | Standard Deviation 9.6 |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Length of Hospitalization | 11.5 days | Standard Deviation 7.6 |
Secondary
Modified Rankin Score (mRS) at Discharge
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 2 | 281 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 4 | 399 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 1 | 612 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 5 | 346 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 3 | 216 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 6 | 88 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 0 | 383 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 6 | 211 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 0 | 5447 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 1 | 6427 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 2 | 2131 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 3 | 1393 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 4 | 2163 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Modified Rankin Score (mRS) at Discharge | mRS score 5 | 902 Participants |
Secondary
Number of Patients With Stroke Recurrence During Hospitalization
Number of patients with stroke recurrence during hospitalization.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Number of Patients With Stroke Recurrence During Hospitalization | 369 Participants |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Number of Patients With Stroke Recurrence During Hospitalization | 2039 Participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 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 |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 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 | 28.9 Percentage of participants |
Secondary
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)
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 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 |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 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) | 32.2 Percentage of participants |
Secondary
Percentage of Patients With Hemorrhagic Stroke During Hospitalization
Percentage of patients with hemorrhagic stroke during hospitalization.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Percentage of Patients With Hemorrhagic Stroke During Hospitalization | 6.7 Percentage of subjects |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Percentage of Patients With Hemorrhagic Stroke During Hospitalization | 3.1 Percentage of subjects |