Efficacy and safety of early tirofiban administration after intravenous thrombolysis in patients with acute ischaemic stroke: the multicentre, randomised, double-blind, placebo-controlled RESCUE BT3 trial protocol

BACKGROUND: Intravenous thrombolysis (IVT) is the standard first-line treatment for patients with acute ischaemic stroke (AIS). However, a significant number of these patients fail to achieve favourable functional outcomes. Early administration of tirofiban may improve functional outcomes in patients who fail to respond to IVT. STUDY DESIGN: The RESCUE BT3 trial is a multicentre, randomised, double-blind, placebo-controlled trial. A total of 1314 AIS patients without large or medium vessel occlusion and with persistent disability after IVT will be randomised in a 1:1 ratio to receive intravenous tirofiban or placebo within 2-24 h after completion of IVT. STUDY ENDPOINTS: The primary efficacy endpoint is the proportion of patients achieving an excellent functional outcome (mRS score 0-1) at 90 days. Secondary endpoints include functional independence (mRS 0-2), ordinal mRS shift, NIHSS change and quality-of-life measures. Safety outcomes include sICH within 48 h and all-cause mortality at 90 days. SUMMARY: This trial aims to determine whether early tirofiban administration after IVT improves functional outcomes without increasing haemorrhagic risk in AIS patients without large or medium vessel occlusion. The results will provide high-quality evidence for adjunctive antiplatelet therapy in this population. TRIAL REGISTRATION: chiCTR2400080653 (www.chictr.org.cn).