NCT00147316

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

Japan Alteplase Clinical Trial (J-ACT): Phase 3 Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Acute Ischemic Stroke Within 3 Hours of Onset

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on previous studies comparing Duteplase ( an 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. The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Conditions

• Cerebral Infarction
• Brain Ischemia

Interventions

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

Timeline

• Start date: 2002-04-01
• Completion: 2003-09-01
• First posted: 2005-09-07
• Last updated: 2026-01-05
• Results posted: 2012-02-24

Locations

1 site across 1 country: Japan