Advancing stroke safety and efficacy through early tirofiban administration after intravenous thrombolysis: The multicenter,randomized,placebo-controlled,double-blind ASSET IT trial protocol

Abstract

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).