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

Recruiting

Phase 3 Results N/A

Trial Description

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.

Detailed Description

THAWS is an investigator initiated Japanese multicenter randomized controlled clinical trial of MRI based thrombolysis in patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset. Intravenous thrombolysis with alteplase of 0.6mg/kg, different from 0.9mg/kg used in other countries, is available as effective and safe treatment of acute stroke within 4.5 hours of symptom onset in Japan. However, time of symptom onset is unknown in about 25% of acute stroke patients. These patients are currently excluded from intravenous thrombolysis with alteplase. The objective of the THAWS project is to provide effective treatment options for acute stroke patients with unknown time of symptom onset. The purpose of this study is to clarify efficacy and safety of MRI-based intravenous thrombolysis with alteplase of 0.6mg/kg for patients with acute wake-up ischemic stroke and those having acute ischemic stroke with unknown time of symptom onset. Eligible patients will be selected based on MRI findings indicative of acute ischemic stroke less than 4.5 hours of age.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: Standard treatment for acute stroke without intravenous alteplase.
    ARM 1: Kind: Experimental
    Label: Standard Care
    Description: Standard treatment for acute stroke
  • Intravenous tissue type plasminogen activator (alteplase) Drug
    Other Names: rt-PA; Activacin; Grtpa; Actilyse; Activase
    ARM 1: Kind: Experimental
    Label: Alteplase
    Description: Intravenous tissue plasminogen activator (alteplase) 0.6mg/kg body-weight up to a maximum of 60 mg, 10% as bolus, 90% over 1 hour as infusion
  • Tissue type plasminogen activator (alteplase) Drug
    Other Names: rt-PA; Activacin; Grtpa; Actilyse; Activase
    Intervention Desc: Comparison between intravenous rt-PA (plus other standard treatment if needed) and standard treatment other than rt-PA
    ARM 1: Kind: Experimental
    Label: Alteplase
    Description: Intravenous tissue plasminogen activator (alteplase) 0.6mg/kg body-weight up to a maximum of 60 mg, 10% as bolus, 90% over 1 hour as infusion
  • Tissue-type plasminogen activator (alteplase) Drug
    Other Names: rt-PA; Activacin; Grtpa; Actilyse; Activase
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Alteplase
    Description: Intravenous tissue-type plasminogen activator (alteplase)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale 0-1 90 days after stroke No
Secondary Categorical shift in National Institutes of Health (NIHSS) score from baseline 24 hours after stroke No
Secondary Categorical shift in NIHSS score from baseline 7 days after stroke No
Secondary Modified Rankin Scale 0-2 90 days after stroke No
Secondary Categorical shift in modified Rankin Scale score from baseline 90 days after stroke No
Secondary Symptomatic intracranial hemorrhage (SICH) in SITS-MOST 24 hours after treatment Yes
Secondary SICH as defined in ECASS II 24 hours after stroke Yes
Secondary SICH as defined in NINDS 24 hours after stroke Yes
Secondary Parenchymal hemorrhage type-2 (PH-2) 24 hours after stroke Yes
Secondary Major bleeding Up to 90 days after stroke Yes
Secondary Modified Rankin Scale 6 90 days after stroke Yes
Secondary sICH as defined in European Cooperative Acute Stroke Study (ECASS) II 24 hours after stroke Yes
Secondary sICH as defined in National Institute of Neurological Disorders and Stroke (NINDS) 24 hours after stroke Yes

Sponsors