Abstract Body: Rationale: Early neurological deterioration (END) following intravenous thrombolysis therapy is a common phenomenon strongly associated with unfavorable outcomes. More than two-thirds of END cases are related to augmented antiplatelet activation, which typically peaks within 2 hours post-thrombolysis initiation, and thus highlights the urgency and necessity of early antiplatelet therapy.
Aims: To evaluate the safety and efficacy of administering 300 mg aspirin within three hours following the initiation of intravenous thrombolysis in improving functional outcomes in patients with AIS, compared to standard antiplatelet therapy.
Sample size estimates: The sample size of 1184 patients will allow the mRS score of 0-1 at 90 days with an estimated difference of 8% (early aspirin treatment versus standard therapy) to be detected with 80% power at 5% significance (two-sided).
Design: The trial is a multicenter, randomized, placebo-controlled trial conducted in China. In total, 1,184 patients will be enrolled if they are eligible for intravenous thrombolysis using Alteplase or Tenecteplase. All enrolled patients will be randomly assigned in a 1:1 ratio to receive either early aspirin antiplatelet therapy within three hours following thrombolysis or standard antiplatelet therapy 24 hours after intravenous thrombolysis. Data collection will be performed via a secure internet site with real-time data validation.
Study outcomes: The primary outcome is a favorable functional outcome, defined as a mRS score of 0-1 at 90 days. Secondary outcomes include the proportion of patients with mRS scores of 0-1 at 30 days and 0-2 at 90 days; ordinal shift analysis of mRS scores at 90 days; and changes in NIHSS scores. Safety endpoints include symptomatic intracerebral hemorrhage, any intracerebral hemorrhage within 48 hours, systemic bleeding, recurrent stroke or other vascular events, mortality, and other adverse events within 90-day follow-up.
Discussion: The TREND-IVT trial will evaluate the safety and efficacy of early antiplatelet therapy with aspirin in patients with AIS receiving intravenous thrombolysis and may provide a promising strategy for improving the functional outcomes of these patients.
Status: The TREND-IVT trial plans to recruit patients from 40 to 50 centers. It is estimated that the final follow-up will be completed by June 2026.
Registration: The trial is registered with ClinicalTrials.gov, NCT06548971.