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This phase 3, multicentre, double-blind, randomised, placebo-controlled trial evaluated whether early tirofiban infusion improved functional outcomes in patients with acute non-cardioembolic ischemic stroke who received intravenous thrombolysis within 4.5 hours of symptom onset and were ineligible for thrombectomy. A total of 832 patients from 38 centres in China were randomised to receive a 24-hour intravenous infusion of tirofiban (n=414) or placebo (n=418) within 60 minutes after thrombolysis; 75% received alteplase and 25% received tenecteplase. The primary endpoint was excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days. Excellent functional outcome occurred in 65.9% of patients receiving tirofiban versus 54.9% receiving placebo (risk ratio, 1.20; 95% CI, 1.07–1.34; p=0.001). Symptomatic intracranial haemorrhage within 36 hours occurred in 1.7% of the tirofiban group and none of the placebo group. Ninety-day mortality was similar between groups (4.1% vs 3.8%). The authors concluded that early tirofiban increased the likelihood of excellent functional recovery after thrombolysis, although the increased incidence of symptomatic intracranial haemorrhage highlights the need to balance potential benefit against bleeding risk.
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This phase 3, multicentre, double-blind, randomised, placebo-controlled trial evaluated whether early tirofiban infusion improved functional outcomes in patients with acute non-cardioembolic ischemic stroke who received intravenous thrombolysis within 4.5 hours of symptom onset and were ineligible for thrombectomy. A total of 832 patients from 38 centres in China were randomised to receive a 24-hour intravenous infusion of tirofiban (n=414) or placebo (n=418) within 60 minutes after thrombolysis; 75% received alteplase and 25% received tenecteplase. The primary endpoint was excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days. Excellent functional outcome occurred in 65.9% of patients receiving tirofiban versus 54.9% receiving placebo (risk ratio, 1.20; 95% CI, 1.07–1.34; p=0.001). Symptomatic intracranial haemorrhage within 36 hours occurred in 1.7% of the tirofiban group and none of the placebo group. Ninety-day mortality was similar between groups (4.1% vs 3.8%). The authors concluded that early tirofiban increased the likelihood of excellent functional recovery after thrombolysis, although the increased incidence of symptomatic intracranial haemorrhage highlights the need to balance potential benefit against bleeding risk.
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