Trial Outcomes & Findings for 1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients (NCT NCT05395338)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

12551 participants

Primary outcome timeframe

Up to 1 year.

Results posted on

2024-10-16

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) 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.

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.

Participant milestones

Participant milestones
Measure	IV Rt-PA Cohort Patients who received IV rt-PA within 4.5 hours of symptom onset	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
Overall Study STARTED	8014	4537
Overall Study Propensity Score Matched Patients	3247	3247
Overall Study COMPLETED	8014	4537
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=3247 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3247 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment	Total n=6494 Participants Total of all reporting groups
Age, Continuous	70.2 Years STANDARD_DEVIATION 11.6 • n=3247 Participants	70.2 Years STANDARD_DEVIATION 12.9 • n=3247 Participants	70.2 Years STANDARD_DEVIATION 12.3 • n=6494 Participants
Sex: Female, Male Female	1303 Participants n=3247 Participants	1318 Participants n=3247 Participants	2621 Participants n=6494 Participants
Sex: Female, Male Male	1944 Participants n=3247 Participants	1929 Participants n=3247 Participants	3873 Participants n=6494 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=3247 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3247 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment
All-cause Mortality at 1 Year (Percentage of Patients With Modified Rankin Scale (mRS) Score =6)	11.1 Percentage of Participants Interval 10.0 to 12.2	12.2 Percentage of Participants Interval 11.1 to 13.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=3083 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3083 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment
Percentage of Patients With Functional Independence (mRS Score 0 to 2) at 1 Year	70.9 Percentage of Participants Interval 69.3 to 72.5	66.4 Percentage of Participants Interval 64.7 to 68.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=3083 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3083 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment
Percentage of Patients With Favourable Outcome (mRS Score 0 to 1) at 1 Year	59.5 Percentage of participants Interval 57.8 to 61.2	54.6 Percentage of participants Interval 52.8 to 56.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=3083 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3083 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment
Percentage of Patients With mRS Score 5 to 6 at 1 Year	15.9 Percentage of participants Interval 14.6 to 17.2	20.3 Percentage of participants Interval 18.9 to 21.7

SECONDARY outcome

Timeframe: 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.

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'.

Outcome measures

Outcome measures
Measure	IV Rt-PA Cohort n=3083 Participants Patients who received IV rt-PA within 4.5 hours of symptom onset	Non-reperfusion Cohort n=3083 Participants Patients who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive any reperfusion treatment
Distribution of mRS Score at 1 Year	1.8 Score on a scale Standard Deviation 2.0	2.0 Score on a scale Standard Deviation 2.1

Adverse Events

IV Rt-PA Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 360 deaths

Non-reperfusion Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 396 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: 018002430127

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.
Publication restrictions are in place

Restriction type: OTHER