Extending the Time for Thrombolysis in Emergency Neurological Deficits "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 (measured by MRI criteria) at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.

Conditions

Interventions

  • Tissue plasminogen activator (Activase®)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic
  • 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: IV tPA
    Description: intravenous tissue plasminogen activator

Trial Design

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

Patient Involvement

Patient will be randomized to one of two arms: 1) Tissue Plasminogen Activator 0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour or 2) placebo IV. Patients will receive mR at 3 months for follow-up.

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 Depression (Montgomery-Asberg Depression Rating Scale [MADRS]) 3 and 12 months No
Secondary Quality of life (Stroke Impact Scale) 3 and 12 months No

Sponsors