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

NCT00412867 | Completed Phase 4 Results

• 1 other identifier: 527-0611
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current literature.

Conditions

Stroke

Keywords

Cerebral Infarction; acute ischemic stroke; Brain ischemia

Outcome Measures

Primary Outcomes (3)

• Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)

  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.

  within 6 hours, from 24 to 36 hours after onset

• Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months

  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.

  3 months after onset

• Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours

  The number of patients with sICH

  within 36 hours after starting treatment

Secondary Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS) Score

  within 6 hours, from 24 to 36 hours, 3 months after onset.

• Barthel Index (BI)

  the day of discharge within 3 months after onset, and 3 months after onset

• Percentage of Participants With Adverse Events and Adverse Drug Reactions

  3 months

Study Arms (1)

Alteplase

EXPERIMENTAL

0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Drug: Alteplase

Interventions

Alteplase DRUG

0.6 mg/kg of Alteplase is intravenously administered

Also known as: Tissue Plasminogen Activator, GRTPA, ACTIVACIN

Alteplase

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset.
• Patients who have been revealed to have occlusion on one side of the middle cerebral artery (M1 or M2 portion) on MRA before the start of treatment.
• Patients for whom consent has been obtained from either themselves or from their legally acceptable representatives in written form.

You may not qualify if:

• Patients with very light neurological symptoms (an NIHSS score of \<= 4) or with rapidly improving symptoms before the start of treatment.
• Patients with serious neurological disorders (an NIHSS score of \>= 23), or serious consciousness disorders (a Japan Coma Scale score of \>= 100) before the start of treatment.
• Patients with functional disorders (a mRS score of \>= 2) before stroke onset.
• Patients who have been administered drugs that are not allowed to be administered concomitantly with alteplase (other thrombolytic agents) after the stroke onset.
• Patients who have been revealed to have extensive early ischemic change (an Alberta Stroke Program Early CT score of \<= 6) on computed tomography (CT) before treatment.
• Patients who have been revealed to have obvious occlusion in the blood vessel except for the middle cerebral artery on MRA before treatment.
• Patients who are forbidden to undergo magnetic resonance imaging (MRI).
• Patients who are defined as having cerebral hemorrhage or subarachnoid hemorrhage (SAH) on CT before treatment.
• Patients whose symptoms suggest SAH.
• Patients with hemorrhage (gastrointestinal hemorrhage, urinary hemorrhage, retroperitoneal hemorrhage, or hemoptysis).
• Patients with a platelet count below 100,000/mm3.
• Patients with fasting blood glucose levels of \< 50 mg/dL or \> 400 mg/dL.
• Patients whose activated partial thromboplastin time (APTT) is prolonged due to heparin administration within 48 hours before stroke onset.
• Patients who have been administered oral anticoagulants with values of the international normalized ratio of prothrombin time (PT-INR) of \> 1.7.
• Patients who have a systolic blood pressure of \> 185 mmHg or a diastolic blood pressure of \> 110 mmHg.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (1)

Investigational site 01

Hokkaido, Japan

Location

Related Publications (2)

• Mori E, Minematsu K, Nakagawara J, Yamaguchi T, Sasaki M, Hirano T; Japan Alteplase Clinical Trial II Group. Effects of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in middle cerebral artery occlusion: Japan Alteplase Clinical Trial II (J-ACT II). Stroke. 2010 Mar;41(3):461-5. doi: 10.1161/STROKEAHA.109.573477. Epub 2010 Jan 14.

  PMID: 20075341 RESULT

• Hirano T, Sasaki M, Mori E, Minematsu K, Nakagawara J, Yamaguchi T; Japan Alteplase Clinical Trial II Group. Residual vessel length on magnetic resonance angiography identifies poor responders to alteplase in acute middle cerebral artery occlusion patients: exploratory analysis of the Japan Alteplase Clinical Trial II. Stroke. 2010 Dec;41(12):2828-33. doi: 10.1161/STROKEAHA.110.594333. Epub 2010 Oct 28.

  PMID: 21030700 DERIVED

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Ischemic Stroke; Brain Ischemia

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Takenori Yamaguchi, M.D.

  National Cerebral and Cardiovascular Center, Japan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 5, 2026
• Results First Posted: February 24, 2012

Record last verified: 2025-12

Locations

JP (1)