Key result
Early aspirin post-IVT is being evaluated against placebo for achieving mRS 0-1 in acute ischemic stroke.
Why the study?
Early neurological deterioration frequently occurs after intravenous thrombolysis for acute ischemic stroke, but whether early antiplatelet therapy improves recovery without increasing bleeding risk remains uncertain.
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?
RCT
Placebo-controlled
1:1
Yes
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?
Clinicians should delay antiplatelets 24h after IVT; this RCT leaves open whether aspirin within 3h improves recovery without excess bleeding.
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
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Zhao et al. (2026) conducted an RCT in Acute ischemic stroke. Aspirin vs. Placebo within 3 hours after IVT was evaluated on Excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0–1 at 90 days. 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.
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