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Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Japan Alteplase Clinical Trial Ⅱ:J-ACT Ⅱ)

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ClinicalTrials.gov Identifier: NCT00412867
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : February 24, 2012
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Kyowa Hakko Kirin Co., Ltd
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Intervention Drug: Alteplase
Enrollment 58
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 58
Completed 58
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 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
70.3  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
23
  39.7%
Male
35
  60.3%
1.Primary Outcome
Title Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
Hide Description

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.

Time Frame within 6 hours, from 24 to 36 hours after onset
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 58
Measure Type: Number
Unit of Measure: participants
within 6 hours after onset 30
from 24 to 36 hours after onset 40
2.Primary Outcome
Title Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months
Hide Description The 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.
Time Frame 3 months after onset
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 58
Measure Type: Number
Unit of Measure: participants
27
3.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 after starting treatment
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 58
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title National Institutes of Health Stroke Scale (NIHSS) Score
Hide Description from 0 (normal) to 40 (most severe)
Time Frame within 6 hours, from 24 to 36 hours, 3 months after onset.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two participants (from 24 to 36 hours) and four participants (3 months after onset) were excluded from analysis because of dropouts or missing data
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 58
Median (Full Range)
Unit of Measure: units on a scale
within 6 hours Number Analyzed 58 participants
8.5
(0 to 20)
from 24 to 36 hours Number Analyzed 56 participants
7.0
(0 to 22)
3 months after onset Number Analyzed 54 participants
1.5
(0 to 32)
5.Secondary Outcome
Title Barthel Index (BI)
Hide Description from 100 (Independent) to 0 (full assistance)
Time Frame the day of discharge within 3 months after onset, and 3 months after onset
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
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 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
the day of discharge within 3 months after onset Number Analyzed 47 participants
76.2  (32.4)
3 months after onset Number Analyzed 54 participants
77.8  (33.2)
6.Secondary Outcome
Title Percentage of Participants With Adverse Events and Adverse Drug Reactions
Hide Description [Not Specified]
Time Frame 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 58
Measure Type: Number
Unit of Measure: percentage of patients
Percentage of Patients with Adverse Events 96.6
Percentage of Patients with Adverse Drug Reactions 41.4
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alteplase (Non-Haemorrhage) Alteplase (Haemorrhage)
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 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 (Non-Haemorrhage) Alteplase (Haemorrhage)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alteplase (Non-Haemorrhage) Alteplase (Haemorrhage)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/58 (20.69%)   1/58 (1.72%) 
Cardiac disorders     
Cardiac failure  2/58 (3.45%)  0/58 (0.00%) 
Sick sinus syndrome  2/58 (3.45%)  0/58 (0.00%) 
Acute left ventricular failure  1/58 (1.72%)  0/58 (0.00%) 
Gastrointestinal disorders     
Inguinal hernia  1/58 (1.72%)  0/58 (0.00%) 
Melaena  0/58 (0.00%)  1/58 (1.72%) 
Hepatobiliary disorders     
Cholecystitis  1/58 (1.72%)  0/58 (0.00%) 
Infections and infestations     
Pneumonia  2/58 (3.45%)  0/58 (0.00%) 
Septic shock  1/58 (1.72%)  0/58 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1/58 (1.72%)  0/58 (0.00%) 
Uterine leiomyoma  1/58 (1.72%)  0/58 (0.00%) 
Nervous system disorders     
Cerebral infarction  4/58 (6.90%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration  1/58 (1.72%)  0/58 (0.00%) 
1
Term from vocabulary, 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Alteplase (Non-Haemorrhage) Alteplase (Haemorrhage)
Affected / at Risk (%) Affected / at Risk (%)
Total   51/58 (87.93%)   25/58 (43.10%) 
Cardiac disorders     
Atrial fibrillation  3/58 (5.17%)  0/58 (0.00%) 
Bradycardia  2/58 (3.45%)  0/58 (0.00%) 
Mitral valve incompetence  4/58 (6.90%)  0/58 (0.00%) 
Tachycardia  3/58 (5.17%)  0/58 (0.00%) 
Tricuspid valve incompetence  3/58 (5.17%)  0/58 (0.00%) 
Gastrointestinal disorders     
Constipation  27/58 (46.55%)  0/58 (0.00%) 
Diarrhoea  7/58 (12.07%)  0/58 (0.00%) 
Mouth haemorrhage  0/58 (0.00%)  3/58 (5.17%) 
Nausea  2/58 (3.45%)  0/58 (0.00%) 
Vomiting  6/58 (10.34%)  0/58 (0.00%) 
General disorders     
Pyrexia  5/58 (8.62%)  0/58 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  10/58 (17.24%)  0/58 (0.00%) 
Liver disorder  4/58 (6.90%)  0/58 (0.00%) 
Infections and infestations     
Nasopharyngitis  4/58 (6.90%)  0/58 (0.00%) 
Urinary tract infections  10/58 (17.24%)  0/58 (0.00%) 
Investigations     
Alanine aminotransferase increased  2/58 (3.45%)  0/58 (0.00%) 
Aspartate aminotransferase increased  2/58 (3.45%)  0/58 (0.00%) 
Blood bilirubin increased  2/58 (3.45%)  0/58 (0.00%) 
Blood creatine phosphokinase increased  7/58 (12.07%)  0/58 (0.00%) 
Blood fibrinogen increased  2/58 (3.45%)  0/58 (0.00%) 
Blood lactate dehydrogenase increased  2/58 (3.45%)  0/58 (0.00%) 
Blood pressure increased  2/58 (3.45%)  0/58 (0.00%) 
Blood urea increased  3/58 (5.17%)  0/58 (0.00%) 
Blood urine present  2/58 (3.45%)  0/58 (0.00%) 
Liver function test abnormal  2/58 (3.45%)  0/58 (0.00%) 
Protein urine present  3/58 (5.17%)  0/58 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  2/58 (3.45%)  0/58 (0.00%) 
Hyponatraemia  3/58 (5.17%)  0/58 (0.00%) 
Hyperlipidaemia  3/58 (5.17%)  0/58 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  2/58 (3.45%)  0/58 (0.00%) 
Back pain  6/58 (10.34%)  0/58 (0.00%) 
Musculoskeletal pain  5/58 (8.62%)  0/58 (0.00%) 
Osteoarthritis  2/58 (3.45%)  0/58 (0.00%) 
Pain in extremity  3/58 (5.17%)  0/58 (0.00%) 
Periarthritis  2/58 (3.45%)  0/58 (0.00%) 
Nervous system disorders     
Cervicobrachial syndrome  2/58 (3.45%)  0/58 (0.00%) 
Haemorrhagic cerebral infarction  0/58 (0.00%)  21/58 (36.21%) 
Headache  5/58 (8.62%)  0/58 (0.00%) 
Psychiatric disorders     
Insomnia  13/58 (22.41%)  0/58 (0.00%) 
Restlessness  3/58 (5.17%)  0/58 (0.00%) 
Renal and urinary disorders     
Dysuria  2/58 (3.45%)  0/58 (0.00%) 
Haematuria  0/58 (0.00%)  2/58 (3.45%) 
Neurogenic bladder  6/58 (10.34%)  0/58 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  2/58 (3.45%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  2/58 (3.45%)  0/58 (0.00%) 
Pneumonia aspiration  3/58 (5.17%)  0/58 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  3/58 (5.17%)  0/58 (0.00%) 
Erythema  5/58 (8.62%)  0/58 (0.00%) 
Haemorrhage subcutaneous  0/58 (0.00%)  5/58 (8.62%) 
Skin exfoliation  2/58 (3.45%)  0/58 (0.00%) 
Vascular disorders     
Deep vein thrombosis  2/58 (3.45%)  0/58 (0.00%) 
1
Term from vocabulary, 11.0
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.
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.
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00412867     History of Changes
Obsolete Identifiers: NCT00412945
Other Study ID Numbers: 527-0611
First Submitted: December 17, 2006
First Posted: December 19, 2006
Results First Submitted: January 19, 2012
Results First Posted: February 24, 2012
Last Update Posted: January 19, 2018