Table 1 Objectives and outcomes of the Tenecteplase in wake-up ischaemic stroke trial
Objectives | Outcome |
|---|---|
Primary | |
Improve functional outcome in participants with wake-up ischemic stroke | Functional outcome defined as shift across the ordinal modified Rankin Scale (mRS) (0–6) at 3 months follow-up |
Secondary | |
Increase the proportion of patients with excellent functional outcome | Proportion of participants free from disability defined as functional outcome mRS score of 0–1 at 3 months follow-up |
Increase the proportion of patients with good functional outcome | Proportion of participants functionally independent defined as an mRS score 0–2 at 3 months follow-up |
Increase the proportion of patients with response to treatment stratified by baseline stroke severity | Proportion of patients with response to treatment; mRS 0 for patients with a mild deficit at study entry (NIHSS <=7), mRS 0-1 for patients with a moderate deficit (NIHSS 8-14), and mRS 0–2 for patients with a severe deficit (NIHSS >14) |
Reduce mortality rate | Proportion of participant mortality over the 3 months study period |
Determine safety based on the rate of symptomatic intracranial hemorrhage (SICH) | Proportion of patients with SICH as defined by the SITS-MOST criteria [8] Proportion of patients with SICH as defined by the IST-3 criteria [9] |
Determine safety based on the rate of parenchymal hemorrhage type 2 (PH-2) [10]a | Proportion of patients with parenchymal hemorrhage type 2 on follow-up imaging at 24 (± 6) h |
Determine safety based on the rate of any intracranial hemorrhage | Proportion of patients with any intracranial hemorrhage detected on follow-up imaging at 24 (± 6) h |
Reduce poor functional outcome or death | Proportion of patients with mRS score of 4–6 at 3 months |