Intravenous tPA trials for acute ischaemic stroke as listed by the year of publication
Year | RCT study | Time window | Group | Conclusion |
1995 | NINDS5 | 0–3 hours | Placebo versus IV tPA 0.9 mg/kg | Improvement of the clinical outcomes at 3 months |
ECASS32 | 0–3 hours | Placebo versus IV tPA 1.1 mg/kg | Improvement of the 90 days’ outcome with increased risk of haemorrhage in particular subgroup | |
1998 | ECASS 2140 | 0–6 hours | Placebo versus IV tPA 0.9 mg/kg | No improvement of the 90-day clinical outcomes |
1999 | ATLANTIS B141 | 3–5 hours | Placebo versus IV tPA 0.9 mg/kg | No improvement of the 90-day outcome with increased risk of haemorrhage |
2000 | ATLANTIS A142 | 0–6 hours | Placebo versus IV tPA 0.9 mg/kg | No improvement of the 90-day clinical outcomes with increased haemorrhage and mortality risk |
2008 | ECASS 3143 | 3–4.5 hours | Placebo versus IV tPA 0.9 mg/kg | Improvement of the 90-day outcome with increased risk of haemorrhage |
2016 | ENCHANTED144 | 0–4.5 hours | IV tPA 0.6 mg/kg versus 0.9 mg/kg | The 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.