Rationale and design of Ticagrelor with Aspirin Dual Antiplatelet Therapy Combined with Intravenous Thrombolysis in Patients with Ischemic Stroke (TAPIS): a multicentre, randomised, double-blind, parallel group, placebo-controlled trial

BACKGROUND AND PURPOSE: Evidence on whether add-on early antiplatelet therapy may improve functional outcome in acute ischaemic stroke (AIS) patients treated with intravenous thrombolysis (IVT) remains inconsistent. This study aims to evaluate the efficacy and safety of oral ticagrelor plus aspirin within 6 hours of symptom onset in IVT-treated AIS patients. METHODS AND DESIGN: Efficacy and Safety of Ticagrelor with Aspirin Dual Antiplatelet Therapy Combined with Intravenous Thrombolysis in Patients with Ischemic Stroke (TAPIS) is a multicentre, randomised, double-blind, parallel-group, placebo-controlled trial. The study will enrol 1380 AIS patients with a pre-IVT National Institutes of Health Stroke Scale (NIHSS) score of 4-10 who have received/are intended to receive IVT with alteplase or tenecteplase within 4.5 hours of onset. Eligible participants will be randomised at a 1:1 ratio within 6 hours of onset, before, during or after IVT. The intervention group will receive a loading dose of ticagrelor tablets (180 mg) and aspirin tablets (100 mg) on day 1, and ticagrelor (90 mg two times per day) plus open-label aspirin (100 mg daily) for days 2-7. The control group will receive ticagrelor placebo and aspirin placebo on day 1, and ticagrelor placebo plus open-label aspirin for days 2-7. Both groups will receive open-label aspirin (100 mg daily) for days 8-90. STUDY OUTCOMES: The primary efficacy outcome is excellent functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0-1. Secondary efficacy outcomes include mRS score of 0-2 at 90 days, distribution of mRS scores at 90 days, NIHSS score at 7 days decreasing by ≥4 points from baseline and recurrent ischaemic stroke within 90 days. The primary safety outcome is symptomatic intracerebral haemorrhage within 36 hours. DISCUSSION: This trial will evaluate whether early dual antiplatelet therapy with ticagrelor plus aspirin could improve functional outcomes of IVT-treated AIS patients. TRIAL REGISTRATION NUMBER: NCT06316570.