STroke imAging pRevention and Treatment-Extending the time for Thrombolysis in Emergency Neurological Deficits "START-EXTEND"

Recruiting

Phase N/A Results N/A

Trial Description

To test the hypothesis that ischaemic stroke patients selected with significant penumbral mismatch at 3 - 9 hours post onset of stroke will have improved clinical outcomes when given intravenous tPA compared to placebo.

Interventions

  • Tissue plasminogen activator (Activase®)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Trial Design

The study will be a randomised, multicentre, double blinded, placebo controlled phase 3 trial (2 arm with 1:1 randomisation) within a larger cohort study of ischaemic stroke patients. Patients randomised to treatment will be stratified for time of randomisation after stroke to within <6 hours and 6-9 hours.

Patient Involvement

Standard care clinical safety laboratory tests, vital signs, physical examination will be done at intake. Patients will be randomized to one of two arms. In addition to standard care clinical bloods, additional blood samples will be collected for biomarkers at baseline, at the time of administration of therapy (T = 0), then at 12-24 hrs, 3 days, 3 months and 12 months post therapy. Imaging is performed with MRI acutely and at 12-24 hours.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) 0 – 1 at 3 months
Secondary Categorical shift in mRS at 3 months; Change in ? 8 NIHSS points or reaching ? 1 on this scale; Death due to any cause; Symptomatic ICH; Reperfusion at 24 hrs post stroke; Recanalisation at 24 hrs post stroke; Infarct growth on DWI within 24 hrs; Recurrent stroke at 12 months; Depression (Montgomery-Asberg Depression Rating Scale [MADRS]) at 3 months and 12 months; Quality of life (Stroke Impact Scale) at 3 months and 12 months.

Sponsors

National Stroke Research Institute (NSRI)