AcT Trial: Protocol for a Pragmatic Registry‐Linked Randomized Clinical Trial

BackgroundIntravenous thrombolysis with alteplase is widely used in patients with acute ischemic stroke presenting early after symptom onset. Recent phase II trials have suggested that intravenous tenecteplase may be safer and associated with higher early reperfusion rates as compared with alteplase...

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Published in:Stroke: vascular and interventional neurology 2022-09, Vol.2 (5)
Main Authors: Sajobi, Tolulope, Singh, Nishita, Almekhlafi, Mohammed A., Buck, Brian, Ademola, Ayoola, Coutts, Shelagh B., Deschaintre, Yan, Khosravani, Houman, Appireddy, Ramana, Moreau, Francois, Phillips, Stephen, Gubitz, Gord, Tkach, Aleksander, Catanese, Luciana, Dowlatshahi, Dar, Medvedev, George, Mandzia, Jennifer, Pikula, Aleksandra, Shankar, J.J., Williams, Heather, Field, Thalia S., Manosalva, Alejandro, Siddiqui, Muzaffar, Zafar, Atif, Imoukhoude, Oje, Hunter, Gary, Sehgal, Arshia, Zhang, Qiao, Doram, Craig, Hill, Michael D., Shamy, Michel, Kenney, Carol, Swartz, Richard H., Menon, Bijoy K.
Format: Article
Language:English
Subjects:
acute stroke
Clinical trials
consent
emergency
ethics
Ischemia
pragmatic
Stroke
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Summary:BackgroundIntravenous thrombolysis with alteplase is widely used in patients with acute ischemic stroke presenting early after symptom onset. Recent phase II trials have suggested that intravenous tenecteplase may be safer and associated with higher early reperfusion rates as compared with alteplase. This study investigates whether intravenous tenecteplase is noninferior to intravenous alteplase for the treatment of acute ischemic stroke.MethodsThis is a pragmatic, registry‐linked, prospective, randomized (1:1) controlled, open‐label parallel group clinical trial (AcT [Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke]) with blinded end point assessment of 1600 patients to test if intravenous tenecteplase (0.25 mg/kg body weight, maximum dose 25 mg) is noninferior to intravenous alteplase (0.9 mg/kg body weight; maximum dose, 90 mg) in patients with acute ischemic stroke eligible for intravenous thrombolysis in clinical routine. Patients are recruited from comprehensive and primary stroke centers and enrolled using deferral of consent. The proposed sample has at least 90% power with a noninferiority margin of 5%, assuming incidence of the 90‐day modified Rankin Scale score of 0 to 1 is 38% in the tenecteplase and 35% in the alteplase groups, and a loss to follow‐up rate
ISSN:2694-5746
2694-5746
DOI:10.1161/SVIN.122.000447