Stroke
Conditions
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
Recombinant Tissue Plasminogen Activator
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | Up to 3 months | 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. |
| All-cause Mortality During Hospitalisation | Up to 3 months | 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. |
| Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | 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). | 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 Year | 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). | 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 Year | 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). | 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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,560 |
Baseline characteristics
| Characteristic | IV Rt-PA Cohort | Non-reperfusion Cohort | Total |
|---|---|---|---|
| Age, Continuous | 85.2 Years STANDARD_DEVIATION 3.4 | 85.3 Years STANDARD_DEVIATION 3.7 | 85.2 Years STANDARD_DEVIATION 3.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 413 Participants | 396 Participants | 809 Participants |
| Sex: Female, Male Male | 367 Participants | 384 Participants | 751 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 308 / 780 | 303 / 780 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | 27.7 Percentage of Participants |
| Non-reperfusion Cohort | Percentage of Patients With Favourable Outcome (Modified Rankin Scale (mRS) 0-1) at 1 Year | 23.8 Percentage of Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | All-cause Mortality at 1 Year | 36.2 Percentage of Participants |
| Non-reperfusion Cohort | All-cause Mortality at 1 Year | 31.5 Percentage of Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | All-cause Mortality During Hospitalisation | 4.5 Percentage of Participants |
| Non-reperfusion Cohort | All-cause Mortality During Hospitalisation | 2.8 Percentage of Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Rt-PA Cohort | Distribution of Modified Rankin Scale (mRS) Score at 1 Year | 3.5 Units on a scale | Standard Deviation 2.4 |
| Non-reperfusion Cohort | Distribution of Modified Rankin Scale (mRS) Score at 1 Year | 3.7 Units on a scale | Standard Deviation 2.3 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | 13.7 Percentage of Participants |
| Non-reperfusion Cohort | Percentage of Patients With Any Intracranial Haemorrhage (ICH) During Hospitalisation | 10.8 Percentage of Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Rt-PA Cohort | Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | 37.3 Percentage of Participants |
| Non-reperfusion Cohort | Percentage of Patients With Independence (Modified Rankin Scale (mRS) 0-2) at 1 Year | 33.7 Percentage of Participants |