ADJUVANT Randomized Controlled Trial: Rationale and Design

Area of Science:

• Neurology
• Cardiology
• Clinical Trials

Background:

• Endovascular thrombectomy (EVT) with intravenous thrombolysis is standard for acute ischemic stroke from large-vessel occlusion.
• Glycoprotein IIb/IIIa inhibitors like tirofiban are explored for thrombosis management.
• The efficacy of tirofiban as an alternative to thrombolysis before EVT is not well-established.

Purpose of the Study:

• To assess if intravenous tirofiban plus EVT is noninferior to intravenous thrombolysis bridging with EVT.
• To evaluate tirofiban as an alternative adjuvant therapy in acute ischemic stroke patients eligible for thrombolysis.

Main Methods:

• The ADJUVANT trial is a multicenter, randomized, open-label, noninferiority study.
• 976 thrombolysis-eligible stroke patients with large-vessel occlusion will be randomized 2:1.
• Participants receive either intravenous tirofiban + EVT or intravenous thrombolysis + EVT.

Main Results:

• The primary efficacy outcome is functional independence (modified Rankin scale 0-2) at 90 days.
• Key safety outcomes include symptomatic intracranial hemorrhage and 90-day mortality.

Conclusions:

• The ADJUVANT trial will offer critical data on tirofiban's efficacy and safety.
• Findings will inform treatment strategies for acute ischemic stroke patients undergoing EVT.