Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial: study protocol

Area of Science:

• Neurology
• Interventional Neuroradiology
• Clinical Trials

Background:

• Mechanical thrombectomy (MT) is a standard treatment for large vessel occlusion (LVO) stroke.
• The role of rescue intra-arterial thrombolysis following successful MT requires further validation in randomized trials.
• Optimizing reperfusion strategies is crucial for improving clinical outcomes in acute ischemic stroke.

Purpose of the Study:

• To confirm if adjunctive intra-arterial alteplase administered after successful MT improves clinical outcomes in LVO stroke patients.
• The Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial aims to provide definitive evidence on this therapeutic strategy.

Main Methods:

• A multicenter, randomized, open-label, phase III trial with blinded endpoint assessment.
• 440 adult patients with symptomatic LVO undergoing successful or complete reperfusion via MT will be enrolled.
• Patients will be randomized 1:1 to receive intra-arterial thrombolysis (alteplase infusion) or standard care.

Main Results:

• The primary outcome is the proportion of patients achieving excellent functional outcome (modified Rankin Scale score of 0-1) at 90 days.
• Secondary outcomes include assessment of hypoperfusion, infarct expansion, functional independence (Barthel Index), quality of life, mortality, and symptomatic intracerebral hemorrhage.

Conclusions:

• This trial is designed to provide robust evidence on the efficacy of rescue intra-arterial thrombolysis in LVO stroke patients.
• Findings will determine if adjunctive alteplase improves functional outcomes and safety profiles after successful mechanical thrombectomy.