Alteplase Compared to Tenecteplase in patients with Acute Ischemic Stroke (AcT) Trial: Protocol for a Pragmatic Registry linked Randomized Clinical Trial

Background : Intravenous thrombolysis with alteplase is widely used in acute ischemic stroke patients presenting early after symptom onset. Recent phase II trials have suggested that intravenous tenecteplase may be safer and associated higher reperfusion rates as compared to alteplase. This study investigates whether non?inferior for the treatment of stroke. Methods a pragmatic, registry?linked, prospective, randomized (1:1) controlled, open?label parallel group clinical trial blinded endpoint assessment 1600 test if (0.25 mg/kg body weight, max dose 25 mg) (0.9 90 eligible routine. Patients are recruited from comprehensive primary centers enrolled using deferral consent. The proposed sample has at least 90% power non?inferiority margin 5%, assuming incidence 90?day mRS 0–1 38% 35% groups, loss follow?up rate < 5%. Results proportion subjects achieving (modified Rankin scale) 0–1. Key safety outcomes include 24?hour symptomatic intracerebral hemorrhage all?cause mortality. All serious adverse events within period will reported coded MedDRA. Outcomes collected either centrally (primary, key secondary endpoints) or through ongoing Canadian registries. analysis simple unadjusted comparison proportions. Conclusion provide real?world evidence effectiveness vs. Clinical Trial Registration: NCT03889249 https://clinicaltrials.gov/ct2/show/NCT03889249 article protected by copyright. rights reserved