BACKGROUND

Intravenous thrombolysis (IVT) is the cornerstone treatment for the acute ischemic stroke (AIS) within 4.5 h after onset. Current guidelines recommend administering antiplatelet medications 24 h after IVT. However, vascular reocclusion is a common occurrence after IVT. Tirofiban, a platelet glycoprotein IIb/IIIa antagonist, can help deter macrovascular reocclusion, prevent microvascular thrombosis, and enhance cerebral blood flow.

OBJECTIVE

This trial aims to assess whether early administration of tirofiban can improve clinical outcomes in patients with AIS who received IVT.

METHODS AND DESIGN

The Advancing Stroke Safety and Efficacy through Early Tirofiban Administration after Intravenous Thrombolysis (ASSET IT) Trial is an investigator-initiated, randomized, placebo-controlled, double-blind, multicenter study. Up to 832 eligible patients will be consecutively randomized in a 1:1 ratio to receive either intravenous tirofiban or placebo over a period of 2 years across 38 stroke centers in China.

OUTCOMES

The primary endpoint is excellent functional status at day 90, defined as a modified Rankin Score of 0-1. Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 h and mortality at 90 days.

TRIAL REGISTRY NUMBER

NCT06134622 (clinicaltrials.gov).