Safety and Efficacy of Early Aspirin Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): Rationale and Design of a Multicenter, Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND

In acute ischemic stroke, early neurological deterioration following intravenous thrombolysis (IVT) is common and is associated with unfavorable outcomes, necessitating antiplatelet therapy. TREND-IVT (Trial of Early Aspirin After Intravenous Thrombolysis for Acute Ischemic Stroke) aims to evaluate the safety and efficacy of 300 mg aspirin administered within 3 hours after the initiation of IVT compared with standard antiplatelet therapy for improving functional outcomes in patients with acute ischemic stroke.

METHODS

This multicenter, randomized, placebo-controlled trial in China recruits patients with acute ischemic stroke receiving IVT (alteplase/tenecteplase) who are not scheduled for endovascular therapy. Participants are randomized in a 1:1 ratio to receive either early aspirin or placebo within 3 hours of initiating IVT, followed by guideline-recommended standard antiplatelet therapy beginning 24 hours after IVT in both groups. The primary outcome is an excellent functional outcome, defined as a modified Rankin Scale (mRS) score 0 to 1 at 90 days. Secondary outcomes will include mRS score 0 to 1 at 30 days, mRS score 0 to 2 at 90 days, ordinal shift analysis of mRS scores at 90 days, and changes in the National Institutes of Health Stroke Scale scores within 7 days. Safety end points will include symptomatic intracerebral hemorrhage, any intracerebral hemorrhage within 48 hours, systemic bleeding, recurrent stroke, other vascular events, mortality, and other adverse events during the 90-day follow-up. A sample size of 1184 participants will provide 80% power to detect an 8% intergroup difference in the primary outcome rate (2-sided α=0.05).

CONCLUSIONS

The trial will evaluate the safety and efficacy of early antiplatelet therapy with oral aspirin in patients with acute ischemic stroke treated with IVT and may provide a promising strategy for improving the functional outcomes in this patient population.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT06548971.