ADJUVANT Randomized Controlled Trial: Rationale and Design

BACKGROUND: Intravenous thrombolysis followed by endovascular thrombectomy (EVT) is a first-line recommended strategy for thrombolysis-eligible patients with stroke due to acute large-vessel occlusion. Tirofiban, one of the most used glycoprotein IIb/IIIa receptor inhibitors, has been increasingly advocated to counteract different stages of thrombosis mediated by activated platelets. It is unclear whether tirofiban could be used as an alternative to thrombolysis as adjuvant medicine for EVT. This trial aims to assess whether intravenous tirofiban plus EVT is noninferior to intravenous thrombolysis bridging with EVT in patients with acute ischemic stroke due to large-vessel occlusion who are eligible for thrombolysis. METHODS: ADJUVANT (Intravenous Tirofiban Versus Thrombolysis Before Endovascular Stroke Thrombectomy) is an investigator-initiated, multicenter, randomized, open-label, noninferiority trial with blinded end point assessment conducted at 42 thrombectomy-capable centers in China. This trial will randomize 976 thrombolysis-eligible stroke patients with confirmed occlusion of the internal carotid artery, M1/M2 segments of the middle cerebral artery, or basilar artery in a 2:1 ratio to receive intravenous tirofiban plus EVT or intravenous thrombolysis bridging with EVT. RESULTS: The primary efficacy outcome is functional independence, defined as a score of 0 to 2 on the modified Rankin scale, at 90 days. Safety outcomes are symptomatic intracranial hemorrhage within 48 hours and death within 90 days. CONCLUSIONS: ADJUVANT will provide unique information about the efficacy and safety of adjuvant intravenous tirofiban before EVT in thrombolysis-eligible patients with stroke due to acute large-vessel occlusion. REGISTRATION: URL: https://clinicaltrials.gov. Unique Identifier: NCT05728333.