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
Fengli Li, Shitao Fan, Changwei Guo, Gaoming Li, Jie Yang, Jiaxing Song, Dahong Yang, Linyu Li, Thanh N Nguyen, Wenjie Zi, Qingwu YangAbstract
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).