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Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00147316
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : February 24, 2012
Last Update Posted : March 1, 2012
Sponsor:
Collaborator:
Kyowa Hakko Kogyo Co., Ltd.
Information provided by:
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cerebral Infarction
Brain Ischemia
Intervention Drug: Alteplase
Enrollment 103

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alteplase
Hide Arm/Group Description 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Period Title: Overall Study
Started 103
Completed 103
Not Completed 0
Arm/Group Title Alteplase
Hide Arm/Group Description 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
70.9  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
39
  37.9%
Male
64
  62.1%
1.Primary Outcome
Title Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months
Hide Description 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.
Time Frame at 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alteplase
Hide Arm/Group Description:
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
38
2.Primary Outcome
Title Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
Hide Description The number of patients with sICH
Time Frame within 36 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alteplase
Hide Arm/Group Description:
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
6
Time Frame 3 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alteplase
Hide Arm/Group Description 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
All-Cause Mortality
Alteplase
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alteplase
Affected / at Risk (%)
Total   29/103 (28.16%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation  1/103 (0.97%) 
Cardiac disorders   
Acute myocardial infarction  1/103 (0.97%) 
Atrial fibrillation  1/103 (0.97%) 
Atrioventricular block complete  1/103 (0.97%) 
Cardiac failure NOS  1/103 (0.97%) 
Ventricular arrhythmia NOS  1/103 (0.97%) 
Infections and infestations   
Infection staphylococcal  1/103 (0.97%) 
Pneumonia NOS  2/103 (1.94%) 
Injury, poisoning and procedural complications   
Brain herniation  1/103 (0.97%) 
Femoral neck fracture  1/103 (0.97%) 
Tracheal obstruction  1/103 (0.97%) 
Traumatic haematoma  1/103 (0.97%) 
Investigations   
C-reactive protein increased  1/103 (0.97%) 
Platelet count decreased  1/103 (0.97%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Left atrial myxoma  1/103 (0.97%) 
Metastases to peritoneum  1/103 (0.97%) 
Nervous system disorders   
Brain oedema  3/103 (2.91%) 
Carotid artery dissection  1/103 (0.97%) 
Cerebral haemorrhage  3/103 (2.91%) 
Cerebral infarction  7/103 (6.80%) 
Haemorrhagic cerebral infarction  2/103 (1.94%) 
Intracranial haemorrhage NOS  1/103 (0.97%) 
Subdural hygroma  1/103 (0.97%) 
Psychiatric disorders   
Depression  1/103 (0.97%) 
Renal and urinary disorders   
Renal failure NOS  1/103 (0.97%) 
Renal impairment NOS  1/103 (0.97%) 
Respiratory, thoracic and mediastinal disorders   
Asthma aggravated  1/103 (0.97%) 
Pneumonia aspiration  2/103 (1.94%) 
Vascular disorders   
Atherosclerosis obliterans  1/103 (0.97%) 
1
Term from vocabulary, 5.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alteplase
Affected / at Risk (%)
Total   91/103 (88.35%) 
Cardiac disorders   
Atrial fibrillation  7/103 (6.80%) 
Ventricular extrasystoles  10/103 (9.71%) 
Gastrointestinal disorders   
Diarrhoea NOS  14/103 (13.59%) 
Gastrointestinal haemorrhage NOS  6/103 (5.83%) 
Periproctitis  6/103 (5.83%) 
Vomiting NOS  14/103 (13.59%) 
General disorders   
Pyrexia  15/103 (14.56%) 
Hepatobiliary disorders   
Hepatic function abnormal NOS  7/103 (6.80%) 
Infections and infestations   
Pneumonia NOS  8/103 (7.77%) 
Urinary tract infection NOS  16/103 (15.53%) 
Nervous system disorders   
Haemorrhagic cerebral infarction  37/103 (35.92%) 
Headache NOS  15/103 (14.56%) 
Renal and urinary disorders   
Haematuria  8/103 (7.77%) 
Neurogenic bladder  7/103 (6.80%) 
Respiratory, thoracic and mediastinal disorders   
Hiccups  6/103 (5.83%) 
Nasopharyngitis  14/103 (13.59%) 
Skin and subcutaneous tissue disorders   
Haemorrhage subcutaneous  22/103 (21.36%) 
Contusion  7/103 (6.80%) 
1
Term from vocabulary, 5.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00147316     History of Changes
Other Study ID Numbers: 527-0110
First Submitted: September 5, 2005
First Posted: September 7, 2005
Results First Submitted: January 19, 2012
Results First Posted: February 24, 2012
Last Update Posted: March 1, 2012