Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke "WAKE-UP"

Active, not recruiting

Phase 3 Results N/A

Trial Description

WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.

Detailed Description

WAKE-UP is a clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Intravenous thrombolysis with Alteplase is available as effective and safe treatment of acute stroke within 4.5 hours of symptom onset. However, in about 20% of acute stroke patients time of symptom onset is unknown. This large group of patients is currently excluded from treatment with Alteplase. The objective of the research proposed in the WAKE-UP project is to provide effective treatment options for this large group of acute stroke patients.
WAKE-UP is designed to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset. Patients will be enrolled based on MRI findings indicative of acute ischemic stroke less than 4.5 hours of age.

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: Intravenous tissue plasminogen activator (Alteplase) 0.9 mg/kg body-weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion
    ARM 1: Kind: Experimental
    Label: intravenous tissue plasminogen activator
    Description: Intervention drug: intravenous tissue plasminogen activator (tPA), alteplase
  • Placebo Drug
    Intervention Desc: lyophilised powder to be reconstituted as solution indistinguishable from the active drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Intervention drug: placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy 90 day after stroke No
Primary Safety 90 day after stroke Yes

Sponsors