Table 1

Intravenous tPA trials for acute ischaemic stroke as listed by the year of publication

YearRCT studyTime windowGroupConclusion
1995NINDS5 0–3 hoursPlacebo versus IV tPA 0.9 mg/kgImprovement of the clinical outcomes at 3 months
ECASS32 0–3 hoursPlacebo versus IV tPA 1.1 mg/kgImprovement of the 90 days’ outcome with increased risk of haemorrhage in particular subgroup
1998ECASS 2140 0–6 hoursPlacebo versus IV tPA 0.9 mg/kgNo improvement of the 90-day clinical outcomes
1999ATLANTIS B141 3–5 hoursPlacebo versus IV tPA 0.9 mg/kgNo improvement of the 90-day outcome with increased risk of haemorrhage
2000ATLANTIS A142 0–6 hoursPlacebo versus IV tPA 0.9 mg/kgNo improvement of the 90-day clinical outcomes with increased haemorrhage and mortality risk
2008ECASS 3143 3–4.5 hoursPlacebo versus IV tPA 0.9 mg/kgImprovement of the 90-day outcome with increased risk of haemorrhage
2016ENCHANTED144 0–4.5 hoursIV tPA 0.6 mg/kg versus 0.9 mg/kgThe incidence of disability did not achieve non-superiority versus standard dose. Less safety concerns
  • All trials used mRS 0–1 as their efficacy outcome measure.

  • ATLANTIS, Alteplase Thrombolysis for Acute Non-interventional Therapy in Ischemic Stroke; ECASS, European Cooperative Acute Stroke Study; ENCHANTED, Enhanced Control of Hypertension and Thrombolysis Stroke Study; IV, intravenous; mRS, modified Rankin Scale; NINDS, National Institute of Neurological Disorders and Stroke; tPA, tissue plasminogen activator.