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

NCT00147316 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-01-05

Study results available
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Summary

Based on previous studies comparing Duteplase\[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase\] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

Conditions

  • Cerebral Infarction
  • Brain Ischemia

Interventions

DRUG

Alteplase

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

Sponsors & Collaborators

  • Kyowa Hakko Kogyo Co., Ltd.

    collaborator INDUSTRY

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Takenori Yamaguchi, MD · National Cerebral and Cardiovascular Center, Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Completion
2003-09-30

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00147316 on ClinicalTrials.gov