TY - JOUR
T1 - The Chemical Optimization of Cerebral Embolectomy trial
T2 - Study protocol
AU - Renú, Arturo
AU - Blasco, Jordi
AU - Millán, Mónica
AU - Martí-Fàbregas, Joan
AU - Cardona, Pere
AU - Oleaga, Laura
AU - Macho, Juan
AU - Molina, Carlos
AU - Roquer, Jaume
AU - Amaro, Sergio
AU - Dávalos, Antonio
AU - Zarco, Federico
AU - Laredo, Carlos
AU - Tomasello, Alejandro
AU - Guimaraens, Leopoldo
AU - Barranco, Roger
AU - Castaño, Carlos
AU - Vivas, Elío
AU - Ramos, Anna
AU - López-Rueda, Antonio
AU - Urra, Xabier
AU - Muchada, Marián
AU - Cuadrado-Godía, Elisa
AU - Camps-Renom, Pol
AU - Román, Luis S.
AU - Ríos, José
AU - Leira, Enrique C.
AU - Jovin, Tudor
AU - Torres, Ferran
AU - Chamorro, Ángel
PY - 2019
Y1 - 2019
N2 - Rationale: The potential value of rescue intraarterial thrombolysis in patients with large vessel occlusion stroke treated with mechanical thrombectomy has not been assessed in randomized trials. Aim: The CHemical OptImization of Cerebral Embolectomy trial aims to establish whether rescue intraarterial thrombolysis is more effective than placebo in improving suboptimal reperfusion scores in patients with large vessel occlusion stroke treated with mechanical thrombectomy. Sample size estimates: A sample size of 200 patients allocated 1:1 to intraarterial thrombolysis or intraarterial placebo will have >95% statistical power for achieving the primary outcome (5% in the control versus 60% in the treatment group) for a two-sided (5% alpha, and 5% lost to follow-up). Methods and design: We conducted a multicenter, randomized, placebo-controlled, double blind, phase 2b trial. Eligible patients are 18 or older with symptomatic large vessel occlusion treated with mechanical thrombectomy resulting in a modified treatment in cerebral ischemia score 2b at end of the procedure. Patients will receive 20–30 min intraarterial infusion of recombinant tissue plasminogen activator or placebo (0.5 mg/ml, maximum dose limit 22.5 mg). Study outcome(s): The primary outcome is the proportion of patients with an improved modified treatment in cerebral ischemia score 10 min after the end of the study treatment. Secondary outcomes include the shift analysis of the modified Rankin Scale, the infarct expansion ratio, the proportion of excellent outcome (modified Rankin Scale 0–1), the proportion of infarct expansion, and the infarction volume. Mortality and symptomatic intracerebral bleeding will be assessed. Discussion: The study will provide evidence whether rescue intraarterial thrombolysis improves brain reperfusion in patients with large vessel occlusion stroke and incomplete reperfusion (modified treatment in cerebral ischemia 2b) at the end of mechanical thrombectomy.
AB - Rationale: The potential value of rescue intraarterial thrombolysis in patients with large vessel occlusion stroke treated with mechanical thrombectomy has not been assessed in randomized trials. Aim: The CHemical OptImization of Cerebral Embolectomy trial aims to establish whether rescue intraarterial thrombolysis is more effective than placebo in improving suboptimal reperfusion scores in patients with large vessel occlusion stroke treated with mechanical thrombectomy. Sample size estimates: A sample size of 200 patients allocated 1:1 to intraarterial thrombolysis or intraarterial placebo will have >95% statistical power for achieving the primary outcome (5% in the control versus 60% in the treatment group) for a two-sided (5% alpha, and 5% lost to follow-up). Methods and design: We conducted a multicenter, randomized, placebo-controlled, double blind, phase 2b trial. Eligible patients are 18 or older with symptomatic large vessel occlusion treated with mechanical thrombectomy resulting in a modified treatment in cerebral ischemia score 2b at end of the procedure. Patients will receive 20–30 min intraarterial infusion of recombinant tissue plasminogen activator or placebo (0.5 mg/ml, maximum dose limit 22.5 mg). Study outcome(s): The primary outcome is the proportion of patients with an improved modified treatment in cerebral ischemia score 10 min after the end of the study treatment. Secondary outcomes include the shift analysis of the modified Rankin Scale, the infarct expansion ratio, the proportion of excellent outcome (modified Rankin Scale 0–1), the proportion of infarct expansion, and the infarction volume. Mortality and symptomatic intracerebral bleeding will be assessed. Discussion: The study will provide evidence whether rescue intraarterial thrombolysis improves brain reperfusion in patients with large vessel occlusion stroke and incomplete reperfusion (modified treatment in cerebral ischemia 2b) at the end of mechanical thrombectomy.
KW - Acute stroke therapy
KW - clinical trial
KW - intervention
KW - ischemic stroke
KW - protocols
KW - recombinant tissue plasminogen activator
KW - reperfusion
KW - stroke
KW - therapy
KW - thrombolysis
UR - http://www.scopus.com/inward/record.url?scp=85077157639&partnerID=8YFLogxK
U2 - 10.1177/1747493019895656
DO - 10.1177/1747493019895656
M3 - Artículo
C2 - 31852410
AN - SCOPUS:85077157639
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4930
ER -