Trial Outcomes & Findings for A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity (NCT NCT04915729)

Last Updated: 2024-12-10

Results Overview

Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1489 participants

Primary outcome timeframe

At Day 90±7 days

Results posted on

2024-12-10

Participant Flow

The main objective of this multi-centre, prospective, randomised, open label, blinded endpoint (PROBE), active-controlled parallel group phase III trial was to assess whether tenecteplase was non-inferior to alteplase in favourable outcome in Chinese patients with acute ischaemic stroke (AIS) who were eligible for intravenous (i.v.) thrombolysis within 4.5 h of symptom onset.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Tenecteplase Treatment Group Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Overall Study STARTED	744	745
Overall Study Treated	733	735
Overall Study COMPLETED	671	675
Overall Study NOT COMPLETED	73	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenecteplase Treatment Group Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Overall Study Lost to Follow-up	20	10
Overall Study Withdrawal by Subject	12	5
Overall Study Death	34	44
Overall Study not treated	3	6
Overall Study Investigator removed subject	1	2
Overall Study questionnaire result not evaluated	1	0
Overall Study refuse of hospital visit	1	3
Overall Study Subject withdrew	1	0

Baseline Characteristics

A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Total n=1465 Participants Total of all reporting groups
Age, Continuous	65.1 Years STANDARD_DEVIATION 11.1 • n=5 Participants	65.0 Years STANDARD_DEVIATION 11.1 • n=7 Participants	65.0 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	231 Participants n=7 Participants	446 Participants n=5 Participants
Sex: Female, Male Male	517 Participants n=5 Participants	502 Participants n=7 Participants	1019 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	732 Participants n=5 Participants	733 Participants n=7 Participants	1465 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline NIHSS total score <6	299 Participants n=5 Participants	297 Participants n=7 Participants	596 Participants n=5 Participants
National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline NIHSS total score 6 - 15	390 Participants n=5 Participants	393 Participants n=7 Participants	783 Participants n=5 Participants
National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline NIHSS total score >=15	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 90±7 days

Population: Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1	72.7 Percentage of participants	70.3 Percentage of participants

SECONDARY outcome

Timeframe: At 24 hours

Population: Full Analysis Set (FAS), This endpoint analysis is based on observed cases, no imputation performed for patients missing NIHSS score at 24h.

Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS \< 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS \> 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=711 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=716 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline	48.0 Percentage of participants	45.0 Percentage of participants

SECONDARY outcome

Timeframe: At Day 90

Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2	80.9 Percentage of participants	79.9 Percentage of participants

SECONDARY outcome

Timeframe: At baseline and at Day 90

Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score	-3.47 score on a scale Standard Error 0.34	-3.02 score on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: At Day 90

Distribution of Modified Rankin Scale (mRS) is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Distribution of Modified Rankin Scale (mRS) mRS score = 0	40.3 Percentage of participants	40.5 Percentage of participants
Distribution of Modified Rankin Scale (mRS) missing	3.8 Percentage of participants	2.3 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 1	30.1 Percentage of participants	28.2 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 2	7.8 Percentage of participants	9.4 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 3	6.7 Percentage of participants	5.5 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 4	4.8 Percentage of participants	6.4 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 5	1.9 Percentage of participants	1.6 Percentage of participants
Distribution of Modified Rankin Scale (mRS) mRS score = 6	4.6 Percentage of participants	6.0 Percentage of participants

SECONDARY outcome

Timeframe: up to 90 days

Population: Full Analysis Set (FAS), No imputation was performed on patients missing Bathel Score at day 90.

The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=699 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=708 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Barthel Index Score ≥95	75.7 Percentage of participants	73.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to 7 days.

Population: Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.

Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period is presented. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=736 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period	1.2 Percentage of participants	1.2 Percentage of participants

SECONDARY outcome

Timeframe: up to 90 days

Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=736 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants Who Died by Day 90	4.6 Percentage of participants	5.8 Percentage of participants

SECONDARY outcome

Timeframe: At Day 90

Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Outcome measures

Outcome measures
Measure	Tenecteplase Treatment Group n=732 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Alteplase Active Control Group n=733 Participants Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6	6.8 Percentage of participants	7.8 Percentage of participants

Adverse Events

Alteplase Active Control Group

Serious events: 115 serious events

Other events: 347 other events

Deaths: 44 deaths

Tenecteplase Treatment Group

Serious events: 116 serious events

Other events: 334 other events

Deaths: 34 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Alteplase Active Control Group n=736 participants at risk Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.	Tenecteplase Treatment Group n=732 participants at risk Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patients performed a 90-day follow-up visit after the treatment to complete the study.
Blood and lymphatic system disorders Anaemia	5.0% 37/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	4.4% 32/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Gastrointestinal disorders Constipation	16.7% 123/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	17.9% 131/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Gastrointestinal disorders Gingival bleeding	10.6% 78/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	10.8% 79/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
General disorders Pyrexia	5.8% 43/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	4.5% 33/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Infections and infestations Pneumonia	8.8% 65/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	7.5% 55/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Infections and infestations Urinary tract infection	6.7% 49/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	6.0% 44/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Metabolism and nutrition disorders Hyperhomocysteinaemia	6.1% 45/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	6.0% 44/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Metabolism and nutrition disorders Hypokalaemia	10.5% 77/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	9.6% 70/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.
Metabolism and nutrition disorders Hypoproteinaemia	5.6% 41/736 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.	4.4% 32/732 • AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days. Safety set (SS): This patient set included all patients who were randomised and received any dose of treatment. It was the main analysis set for presentation of safety. Patients were analysed according to the actual treatment.

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