Trial Outcomes & Findings for Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke (NCT NCT00147316)
NCT ID: NCT00147316
Last Updated: 2026-01-05
Results Overview
The number of patients with a 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
at 3 months
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
|
103
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Alteplase
n=103 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
|
70.9 years
STANDARD_DEVIATION 9.8 • n=9667 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=9667 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=9667 Participants
|
PRIMARY outcome
Timeframe: at 3 monthsThe number of patients with a 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=103 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 at 3 Months
|
38 participants
|
PRIMARY outcome
Timeframe: within 36 hoursThe number of patients with sICH
Outcome measures
| Measure |
Alteplase
n=103 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
|
6 participants
|
Adverse Events
Alteplase
Serious events: 29 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alteplase
n=103 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
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.97%
1/103 • 3 Months
|
|
Investigations
Platelet count decreased
|
0.97%
1/103 • 3 Months
|
|
Infections and infestations
Pneumonia NOS
|
1.9%
2/103 • 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
2/103 • 3 Months
|
|
Renal and urinary disorders
Renal failure NOS
|
0.97%
1/103 • 3 Months
|
|
Renal and urinary disorders
Renal impairment NOS
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Subdural hygroma
|
0.97%
1/103 • 3 Months
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.97%
1/103 • 3 Months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.97%
1/103 • 3 Months
|
|
Cardiac disorders
Ventricular arrhythmia NOS
|
0.97%
1/103 • 3 Months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.97%
1/103 • 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma aggravated
|
0.97%
1/103 • 3 Months
|
|
Vascular disorders
Atherosclerosis obliterans
|
0.97%
1/103 • 3 Months
|
|
Cardiac disorders
Atrial fibrillation
|
0.97%
1/103 • 3 Months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.97%
1/103 • 3 Months
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Brain oedema
|
2.9%
3/103 • 3 Months
|
|
Investigations
C-reactive protein increased
|
0.97%
1/103 • 3 Months
|
|
Cardiac disorders
Cardiac failure NOS
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Carotid artery dissection
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.9%
3/103 • 3 Months
|
|
Nervous system disorders
Cerebral infarction
|
6.8%
7/103 • 3 Months
|
|
Psychiatric disorders
Depression
|
0.97%
1/103 • 3 Months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.97%
1/103 • 3 Months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
1.9%
2/103 • 3 Months
|
|
Infections and infestations
Infection staphylococcal
|
0.97%
1/103 • 3 Months
|
|
Nervous system disorders
Intracranial haemorrhage NOS
|
0.97%
1/103 • 3 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left atrial myxoma
|
0.97%
1/103 • 3 Months
|
Other adverse events
| Measure |
Alteplase
n=103 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
|
6.8%
7/103 • 3 Months
|
|
Cardiac disorders
Ventricular extrasystoles
|
9.7%
10/103 • 3 Months
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
13.6%
14/103 • 3 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
5.8%
6/103 • 3 Months
|
|
Gastrointestinal disorders
Periproctitis
|
5.8%
6/103 • 3 Months
|
|
Gastrointestinal disorders
Vomiting NOS
|
13.6%
14/103 • 3 Months
|
|
General disorders
Pyrexia
|
14.6%
15/103 • 3 Months
|
|
Hepatobiliary disorders
Hepatic function abnormal NOS
|
6.8%
7/103 • 3 Months
|
|
Infections and infestations
Pneumonia NOS
|
7.8%
8/103 • 3 Months
|
|
Infections and infestations
Urinary tract infection NOS
|
15.5%
16/103 • 3 Months
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
35.9%
37/103 • 3 Months
|
|
Nervous system disorders
Headache NOS
|
14.6%
15/103 • 3 Months
|
|
Renal and urinary disorders
Haematuria
|
7.8%
8/103 • 3 Months
|
|
Renal and urinary disorders
Neurogenic bladder
|
6.8%
7/103 • 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.8%
6/103 • 3 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
13.6%
14/103 • 3 Months
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
21.4%
22/103 • 3 Months
|
|
Skin and subcutaneous tissue disorders
Contusion
|
6.8%
7/103 • 3 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER