What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Acute ischemic stroke (n=4595). Intervention: Early antiplatelet therapy vs. Standard timing (>24 h), placebo, or no antiplatelet therapy. Primary outcome: Symptomatic intracranial hemorrhage (sICH) (OR 1.68, 95% CI 0.94-3.01).

May 28, 2026

Safety and efficacy of early antiplatelet therapy after intravenous thrombolysis for acute ischemic stroke; A comprehensive meta-analysis with trial sequential analysis

Key Result

Early antiplatelet therapy within 24 hours of intravenous thrombolysis yielded a non-significant increase in symptomatic intracranial hemorrhage (OR 1.68; 95% CI 0.94-3.01) without functional benefit.

Key Points

To evaluate the safety and efficacy of early antiplatelet therapy after intravenous thrombolysis in acute ischemic stroke patients.
PRISMA-guided systematic review of randomized controlled trials
Compared early antiplatelet therapy initiated within 24 hours after IVT versus standard timing or placebo
Utilized random-effects models for analysis with odds ratios and confidence intervals
Early antiplatelet therapy showed non-significant higher odds of symptomatic intracranial hemorrhage (OR 1.68, 95% CI 0.94–3.01)
Mortality odds were higher but not statistically significant (OR 1.15, 95% CI 0.83–1.58)
No significant improvement in functional outcomes such as mRS 0–1 (OR 1.10, 95% CI 0.83–1.46)

Study Design

Type

Meta-Analysis (n=4,595)

Structured PICO

Does early antiplatelet therapy initiated within 24 hours after intravenous thrombolysis improve functional outcomes or increase hemorrhagic risk in patients with acute ischemic stroke?

Population

12 RCTs pooling 4,595 patients with acute ischemic stroke (AIS) treated with intravenous thrombolysis (IVT) with or without thrombectomy.

Intervention

Early antiplatelet therapy initiated within 24 hours after intravenous thrombolysis (IVT).

Comparator

Standard timing (>24 hours), placebo, or no antiplatelet therapy.

Outcome

Symptomatic intracranial hemorrhage (sICH) and functional outcomes (mRS 0-1 and mRS 0-2).hard clinical

Routine early antiplatelet therapy within 24 hours of intravenous thrombolysis for acute ischemic stroke does not improve functional outcomes and may increase the risk of symptomatic intracranial hemorrhage, particularly with aspirin.

Main Result

Effect estimate: OR 1.68 (95% CI 0.94-3.01)

Limitations

Trial sequential analysis indicated evidence remains inconclusive
Analysis cannot exclude clinically meaningful hemorrhagic harm

Abstract

Background: Early antiplatelet therapy after intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) patients may prevent re-occlusion and early neurological deterioration, but it could increase hemorrhagic transformation. Evidence remains conflicting, particularly with emerging contemporary trials. Methods: We conducted a PRISMA-guided systematic review of randomized controlled trials (RCTs) comparing eAPT initiated within 24 hours after IVT (with or without thrombectomy) versus standard timing (>24 h), placebo, or no antiplatelet therapy (CRD420251276445). Random-effects models were used to estimate odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs). Trial sequential analysis, subgroup analyses, meta-regression, and GRADE certainty ratings were performed. Results: Twelve RCTs with 4,595 patients were included. Early antiplatelet therapy led to higher non-significant odds of symptomatic intracranial hemorrhage (sICH) (OR 1.68, 95% CI 0.94–3.01; I² 10.4%; GRADE moderate), and mortality (OR 1.15, 0.83–1.58; I² 14.8%; GRADE moderate) but not intracranial hemorrhage (OR 1.01, 0.64–1.60; I² 52.6%; GRADE low). Functional outcomes were not improved: mRS 0–1 (OR 1.10, 0.83–1.46; I² 60.5%; GRADE low) and mRS 0–2 (OR 1.27, 0.89–1.80; I² 73.4%; GRADE very low). Trial sequential analysis indicated evidence remains inconclusive. Agent-specific subgroup analyses suggested higher sICH with early aspirin (OR 2.13, 1.02–4.45) and possible benefit for mRS 0–2 with tirofiban (OR 2.07, 1.25–3.43). Conclusions: Routine early antiplatelet therapy within 24 hours after IVT does not provide conclusive functional benefit and our analysis cannot exclude clinically meaningful hemorrhagic harm. Further adequately powered RCTs are needed to define whether any selected regimen -especially tirofiban- has a favorable risk-benefit profile.

Bookmark