Stroke
Conditions
Brief summary
The objective of the study is to find out the 1-year clinical outcomes among Acute Ischaemic Stroke (AIS) patients who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset compared with those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment in a real-world clinical setting.
Interventions
DRUGrt-PA
Recombinant Tissue Plasminogen Activator
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
* Patients registered in the ZSQCC platform from Jan 2017 to Mar 2020 * ≥ 18 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) | Up to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year | Up to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year | Up to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Percentage of Patients With mRS Score 5 to 6 at 1 Year | Up to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Distribution of mRS Score at 1 Year | Up to 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. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'. |
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) patients aged ≥18 years in China aimed to compare the 1-year mortality of AIS patients treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset versus those who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive reperfusion treatment.
Pre-assignment details
Between January 2017 and March 2020, 98,330 AIS patients were registered in the ZSQCC platform. A total of 12,551 patients were included in the study, with 6,494 of them matched 1:1 (3,247 in the IV Rt-PA Cohort and 3,247 in the Non-reperfusion Cohort) based on baseline characteristics using the propensity score matching (PSM) method. Only the propensity score-matched patients as described here were used for the data analyses.
Participants by arm
| Arm | Count |
|---|---|
| IV Rt-PA Cohort Patients who received IV rt-PA within 4.5 hours of symptom onset | 3,247 |
| Non-reperfusion Cohort Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment | 3,247 |
| Total | 6,494 |
Baseline characteristics
| Characteristic | IV Rt-PA Cohort | Non-reperfusion Cohort | Total |
|---|---|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 11.6 | 70.2 Years STANDARD_DEVIATION 12.9 | 70.2 Years STANDARD_DEVIATION 12.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1303 Participants | 1318 Participants | 2621 Participants |
| Sex: Female, Male Male | 1944 Participants | 1929 Participants | 3873 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 360 / 3,247 | 396 / 3,247 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)
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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: Up to 1 year.
Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) | 11.1 Percentage of Participants |
| Non-reperfusion Cohort | All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6) | 12.2 Percentage of Participants |
p-value: 0.18395% CI: [0.78, 1.05]Regression, Cox
Secondary
Distribution of 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. Clinicians give the mRS score per the clinical diagnosis/symptom to the patient. There is no calculation for this endpoint or each individual components. The scale runs from 0-6, from 'perfect health without symptoms' to 'death'.
Time frame: Up to 1 year.
Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Rt-PA Cohort | Distribution of mRS Score at 1 Year | 1.8 Score on a scale | Standard Deviation 2 |
| Non-reperfusion Cohort | Distribution of mRS Score at 1 Year | 2.0 Score on a scale | Standard Deviation 2.1 |
p-value: <0.00195% CI: [0.77, 0.93]Regression, Logistic
Secondary
Percentage of Patients With Favourable Outcome (mRS Score 0 to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: Up to 1 year.
Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year | 59.5 Percentage of participants |
| Non-reperfusion Cohort | Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year | 54.6 Percentage of participants |
p-value: <0.00195% CI: [1.11, 1.36]Regression, Logistic
Secondary
Percentage of Patients With Functional Independence (mRS Score 0 to 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: Up to 1 year.
Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year | 70.9 Percentage of Participants |
| Non-reperfusion Cohort | Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year | 66.4 Percentage of Participants |
p-value: <0.00195% CI: [1.12, 1.39]Regression, Logistic
Secondary
Percentage of Patients With mRS Score 5 to 6 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. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: Up to 1 year.
Population: Propensity score matched (PSM) cohorts of AIS patients between the IV rt-PA and non-reperfusion groups (1:1). Patients \>= 18 years old and registered in the ZSQCC platform from Jan 2017 to Mar 2020. Only patients with available mRS data for this outcome were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With mRS Score 5 to 6 at 1 Year | 15.9 Percentage of participants |
| Non-reperfusion Cohort | Percentage of Patients With mRS Score 5 to 6 at 1 Year | 20.3 Percentage of participants |
p-value: <0.00195% CI: [0.64, 0.83]Regression, Logistic