Trial Outcomes & Findings for Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ） (NCT NCT00412867)
NCT ID: NCT00412867
Last Updated: 2026-01-05
Results Overview
Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in \<50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory. The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
within 6 hours, from 24 to 36 hours after onset
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Alteplase
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
Baseline characteristics by cohort
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 11.5 • n=9667 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=9667 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=9667 Participants
|
PRIMARY outcome
Timeframe: within 6 hours, from 24 to 36 hours after onsetRecanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in \<50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory. The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization.
Outcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
within 6 hours after onset
|
30 participants
|
|
Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
from 24 to 36 hours after onset
|
40 participants
|
PRIMARY outcome
Timeframe: 3 months after onsetThe number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.
Outcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months
|
27 participants
|
PRIMARY outcome
Timeframe: within 36 hours after starting treatmentThe number of patients with sICH
Outcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
|
0 participants
|
SECONDARY outcome
Timeframe: within 6 hours, from 24 to 36 hours, 3 months after onset.Population: Two participants (from 24 to 36 hours) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data
from 0 (normal) to 40 (most severe)
Outcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
National Institutes of Health Stroke Scale (NIHSS) Score
within 6 hours
|
8.5 units on a scale
Interval 0.0 to 20.0
|
|
National Institutes of Health Stroke Scale (NIHSS) Score
from 24 to 36 hours
|
7.0 units on a scale
Interval 0.0 to 22.0
|
|
National Institutes of Health Stroke Scale (NIHSS) Score
3 months after onset
|
1.5 units on a scale
Interval 0.0 to 32.0
|
SECONDARY outcome
Timeframe: the day of discharge within 3 months after onset, and 3 months after onsetPopulation: Eleven participants (the day of discharge within 3 months after onset) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data
from 100 (Independent) to 0 (full assistance)
Outcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Barthel Index (BI)
the day of discharge within 3 months after onset
|
76.2 units on a scale
Standard Deviation 32.4
|
|
Barthel Index (BI)
3 months after onset
|
77.8 units on a scale
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Alteplase
n=58 Participants
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|
|
Percentage of Participants With Adverse Events and Adverse Drug Reactions
Percentage of Patients with Adverse Events
|
96.6 percentage of patients
|
|
Percentage of Participants With Adverse Events and Adverse Drug Reactions
Percentage of Patients with Adverse Drug Reactions
|
41.4 percentage of patients
|
Adverse Events
Alteplase (Non-Haemorrhage)
Serious events: 12 serious events
Other events: 51 other events
Deaths: 0 deaths
Alteplase (Haemorrhage)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alteplase (Non-Haemorrhage)
n=58 participants at risk
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
Alteplase (Haemorrhage)
n=58 participants at risk
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Sick sinus syndrome
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Acute left ventricular failure
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/58 • 3 months
|
1.7%
1/58 • 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Infections and infestations
Septic shock
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Nervous system disorders
Cerebral infarction
|
6.9%
4/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.7%
1/58 • 3 months
|
0.00%
0/58 • 3 months
|
Other adverse events
| Measure |
Alteplase (Non-Haemorrhage)
n=58 participants at risk
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
Alteplase (Haemorrhage)
n=58 participants at risk
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Bradycardia
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Mitral valve incompetence
|
6.9%
4/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Tachycardia
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Cardiac disorders
Tricuspid valve incompetence
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
46.6%
27/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
7/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/58 • 3 months
|
5.2%
3/58 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
6/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
General disorders
Pyrexia
|
8.6%
5/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
17.2%
10/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Hepatobiliary disorders
Liver disorder
|
6.9%
4/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
4/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Infections and infestations
Urinary tract infections
|
17.2%
10/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood bilirubin increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood creatine phosphokinase increased
|
12.1%
7/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood fibrinogen increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood pressure increased
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood urea increased
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Blood urine present
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Liver function test abnormal
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Investigations
Protein urine present
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
6/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.6%
5/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Nervous system disorders
Cervicobrachial syndrome
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/58 • 3 months
|
36.2%
21/58 • 3 months
|
|
Nervous system disorders
Headache
|
8.6%
5/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Psychiatric disorders
Insomnia
|
22.4%
13/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Psychiatric disorders
Restlessness
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Renal and urinary disorders
Dysuria
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/58 • 3 months
|
3.4%
2/58 • 3 months
|
|
Renal and urinary disorders
Neurogenic bladder
|
10.3%
6/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.2%
3/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.6%
5/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/58 • 3 months
|
8.6%
5/58 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
|
Vascular disorders
Deep vein thrombosis
|
3.4%
2/58 • 3 months
|
0.00%
0/58 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor's consent must be obtained in advance if the investigator or other study-related personnel in the study center intend to publish information obtained via this study at a scientific conference or similar venue.
- Publication restrictions are in place
Restriction type: OTHER