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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3

Conditions

Brain Ischemia
Cerebral Infarction

Treatments

Drug: Alteplase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147316
527-0110

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset

Exclusion criteria

  • patients with rapidly improving neurological symptoms or with minor neurological deficit (National Institutes of Health Stroke Scale (NIHSS) score of ≤4) prior to the start of treatment
  • Computed Tomography (CT) evidence of non-minor early ischemic signs (minor early ischemic sign was defined as the involvement of one-third or less of the middle cerebral artery area)
  • CT evidence of cerebral hemorrhage or subarachnoid hemorrhage
  • symptoms suggestive of subarachnoid hemorrhage
  • lactation, pregnancy or suggestive pregnancy; menstruation
  • platelet count below 100,000/mm3
  • heparin administration within 48 hours preceding stroke onset with an elevated activated partial thromboplastin time (APTT); current use of oral anticoagulants with an International Normalized Ratio (INR) of ≥1.7; use of drugs not allowed to be administered concomitantly with alteplase (other thrombolytic agents, ozagrel sodium, argatroban and edaravone) prior to the study treatment
  • major surgery or serious trauma within the preceding 14 days; serious head or spinal cord trauma within the preceding 3 months
  • a history of gastrointestinal or urinary tract hemorrhage within the previous 21 days
  • arterial puncture at a noncompressible site within the preceding 7 days
  • a history of stroke within the preceding 3 months; a history of intracranial hemorrhage or increased risk of intracranial hemorrhage because of cerebral aneurysm, arteriovenous malformation, neoplasm, etc.
  • concurrent severe hepatic or renal dysfunction
  • malignant tumor under treatment
  • a systolic blood pressure of >185 mmHg or diastolic blood pressure of >110 mmHg
  • a need for aggressive treatment to reduce blood pressure to below these limits(14))
  • blood glucose levels of <50 mg/dL or >400 mg/dL
  • acute myocardial infarction(AMI) or endocarditis after AMI
  • concurrent infectious endocarditis, moya-moya disease (Willis circle occlusion syndrome), aortic dissection, neck trauma, etc.; strong suspicion of ischemic cerebrovascular disorder caused by non-thrombotic occlusion or any other hemodynamic condition
  • seizure at the onset of stroke
  • coma (a Japan Coma Scale score of ≥100)
  • an mRS score of ≥2 before stroke onset
  • a history of hypersensitivity to protein preparations
  • difficulty in monitoring for 3 months
  • less than 3 months since any other clinical trial

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 1 patient group

Alteplase
Experimental group
Description:
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Treatment:
Drug: Alteplase

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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