What is the clinical evidence from this study?

Study design: RCT. Population: Acute ischemic stroke. Intervention: Aspirin vs. Placebo within 3 hours after IVT. Primary outcome: Excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days.

What question did this study set out to answer?

This trial aims to determine if early aspirin therapy improves recovery after intravenous thrombolysis without increasing bleeding risk.

May 8, 2026Open Access

Abstract Number: Esoc2026ot166 Safety and Efficacy of Early Aspirin Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (Trend-Ivt): A Multicenter, Randomized, Placebo-Controlled Clinical Trial

Key Result

Early administration of 300 mg aspirin within 3 hours after intravenous thrombolysis is being evaluated against placebo for achieving a 90-day mRS score of 0-1 in patients with acute ischemic stroke.

Key Points

This trial aims to determine if early aspirin therapy improves recovery after intravenous thrombolysis without increasing bleeding risk.
Multicenter, randomized, placebo-controlled trial conducted in China
Patients with acute ischemic stroke received 300 mg aspirin or placebo within 3 hours after thrombolysis initiation
Guideline-recommended antiplatelet therapy started 24 hours post-thrombolysis.
Primary outcome: mRS score 0-1 at 90 days will assess excellent functional outcome.
Secondary outcomes include mRS 0-2 at 90 days and analysis of mRS scores.
Safety outcomes track various bleeding risks and adverse events over 90 days.

Study Design

Type

RCT

Blinding

Placebo-controlled

Randomization

1:1

Multicenter

Yes

Structured PICO

Does early administration of 300 mg aspirin within 3 hours after intravenous thrombolysis improve functional outcomes at 90 days in patients with acute ischemic stroke?

Population

Patients with acute ischemic stroke (AIS) treated with intravenous thrombolysis (alteplase or tenecteplase) and not scheduled for endovascular therapy

Intervention

Aspirin 300 mg administered within 3 hours after initiation of intravenous thrombolysis, followed by guideline-recommended standard antiplatelet therapy initiated 24 hours after IVT

Comparator

Matching placebo administered within 3 hours after initiation of intravenous thrombolysis, followed by guideline-recommended standard antiplatelet therapy initiated 24 hours after IVT

Outcome

Excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days

Abstract

Abstract Background and aims Early neurological deterioration after intravenous thrombolysis (IVT) occurs frequently in patients with acute ischemic stroke (AIS) and is associated with poor functional outcomes. Whether early initiation of antiplatelet therapy after IVT can improve recovery without increasing bleeding risk remains uncertain. Methods To evaluate the safety and efficacy of administering 300 mg aspirin within 3 hours after initiation of IVT compared with delayed, guideline-recommended antiplatelet therapy in patients with AIS. Results This is a multicenter, randomized, placebo-controlled trial conducted in China. Patients with AIS treated with IVT (alteplase or tenecteplase) and not scheduled for endovascular therapy are eligible. Participants are randomized in a 1:1 ratio to receive either early aspirin or placebo within 3 hours after IVT initiation. In both groups, guideline-recommended standard antiplatelet therapy is initiated 24 hours after IVT. Conclusions The primary outcome is excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days. Secondary outcomes include mRS 0–2 and ordinal shift analysis of mRS scores at 90 days. Safety outcomes 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. Conflict of interest