EXTEND (International): Extending the Time for Thrombolysis in Emergency Neurological Deficits (International) "EXTEND"

Recruiting

Phase 3 Results N/A

Trial Description

The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (according to imaging criteria) at 4.5 (or 3 hours depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke' (WUS) will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo provided as 50mg lyophilised powder to be reconstituted with sterile water in glass vials indistinguishable from active drug
    ARM 1: Kind: Experimental
    Label: Placebo
  • Tissue Plasminogen Activator (Alteplase) Drug
    Other Names: Actilyse; Activase; tPA; r-tPA
    Intervention Desc: 0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
    ARM 1: Kind: Experimental
    Label: intravenous tissue plasminogen activator

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) 0-1 3 months No
Secondary Categorical shift in modified Rankin Score (mRS) 3 months No
Secondary Change in ≥ 8 NIHSS points or reaching ≤ 1 on this scale 3 months No
Secondary Death due to any cause 3 months Yes
Secondary Symptomatic ICH 24 hours Yes
Secondary Reperfusion 24 hours No
Secondary Recanalisation 24 hours No
Secondary Infarct growth 24 hours No
Secondary Recurrent stroke 3 and 12 months No
Secondary Change in ≥ 8 National Institutes of Health Stroke Scale (NIHSS) points or reaching ≤ 1 on this scale 3 months No
Secondary Symptomatic Intracerebral Hemorrhage (ICH) 24 hours Yes

Sponsors