ABSTRACT NUMBER: ESOC2026LT10 LT10 - EFFECT OF INTRAVENOUS TIROFIBAN VS PLACEBO AFER INTRAVENOUS TENECTEPLASE ON EXCELLENT OUTCOME IN PATIENTS WITH ACUTE ISCHEMIC STROKE: THE INSTANT RANDOMIZED CLINICAL TRIAL

Abstract Background and aims The safety and efficacy of early administration of tirofiban after intravenous thrombolysis in patients with acute ischemic stroke remains uncertain. Methods In this multicenter, randomized, double-blind, placebo-controlled trial, acute ischemic stroke patients without large or medium-vessel occlusion, without cardioembolic etiology, and who had an insufficient clinical response to intravenous tenecteplase were enrolled. Within 4 to 24 hours after intravenous tenecteplase, patients were randomized in a 1:1 ratio to receive intravenous tirofiban or placebo. The primary outcome was excellent outcome (a score of 0 to 1 on the modified Rankin scale; range, 0 to 6, with higher scores indicating more severe disability) at 90 days. Safety outcomes were symptomatic intracranial hemorrhage within 48 hours and 90-day mortality. Results A total of 359 patients underwent randomization: 177 to the tirofiban group and 182 to the placebo group. Excellent outcome at 90 days was observed in 113 patients (63.8%) in the tirofiban group and in 95 patients (52.5%) in the placebo group (risk ratio, 1.22; 95% confidence interval, 1.02-1.46; P=0.03). Symptomatic intracranial hemorrhage within 48 hours occurred in 1 patient (0.9%) in the tirofiban group and no patients in the placebo group; 90-day mortality was 0.6% and 1.7%, respectively. Conclusions Among acute ischemic stroke patients without large or medium-vessel occlusion or cardioembolic stroke who had an inadequate clinical response to intravenous tenecteplase, early adjunctive tirofiban increased the likelihood of an excellent outcome at 90 days. (Funded by the Ganzhou People's Hospital Talent Training Program and others; ClinicalTrials.gov Identifier: NCT05604638) Conflict of interest