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THrombolysis for Acute Wake-up and Unclear-onset Strokes With Alteplase at 0.6 mg/kg Trial (THAWS)

NCT02002325 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-12-20

No results posted yet for this study

Summary

The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset.

Conditions

Interventions

DRUG

Tissue-type plasminogen activator (alteplase)

Intravenous tissue-type plasminogen activator (alteplase) 0.6mg/kg body-weight up to a maximum of 60 mg, 10% as bolus, 90% over 1 hour as infusion (plus other standard treatment if needed)

OTHER

Standard care

Standard treatment for acute stroke without intravenous alteplase.

Sponsors & Collaborators

  • Charitable Trust Mihara Cerebrovascular Disorder Research Promotion Fund

    collaborator UNKNOWN

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • National Cerebral and Cardiovascular Center, Japan

    lead OTHER

Principal Investigators

  • Kazunori Toyoda, MD · National Cerebral and Cardiovascular Center, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-12-31
Completion
2020-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT02002325 on ClinicalTrials.gov