Early antiplatelet for minor stroke following thrombolysis (EAST): Rationale and design.

BACKGROUND

Early neurological deterioration (END) occurs in about 10% of patients after intravenous thrombolysis (IVT) and is related to poor outcome. In theory, early antiplatelet following IVT could reduce END by preventing re-occlusion and stroke progression, but current guidelines recommend starting antiplatelet treatment at 24 h after IVT due to concerns about hemorrhagic transformation. Given higher risk of hemorrhagic transformation in severe stroke, we hypothesized that minor stroke patients following IVT can safely benefit from early antiplatelet treatment.

AIMS

To explore the efficacy and safety of early antiplatelet in minor stroke patients after IVT.

SAMPLE SIZE ESTIMATES

A maximum of 1022 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by age, gender, history of stroke or transient ischemic attack, history of hypertension, history of diabetes mellitus, systolic blood pressure at admission, time from IVT to treatment, thrombolysis drug, stroke territory, and stroke etiology.

DESIGN

Early antiplatelet for minor stroke following thrombolysis is a prospective, double-blinded, multicenter, randomized and placebo-controlled trial. Minor stroke patients within 6 h following IVT are randomly assigned into experimental group and control group with the ratio of 1:1. The experimental group is orally administered with 300 mg clopidogrel and 100 mg aspirin, and control group with placebo. Subsequently, both groups received guideline-based antithrombotic treatment from 24 h after IVT to 90 days.

OUTCOME

The primary efficacy endpoint is excellent functional outcome, defined as the modified Rankin Scale 0-1 at 90 days after randomization, while primary safety endpoint is symptomatic intracerebral hemorrhage, defined as National Institutes of Health Stroke Scale score increase ⩾ 4 caused by intracranial hemorrhage within 36 h after randomization.

CONCLUSIONS

The results of EAST will provide us powerful early antiplatelet evidence for minor stroke population following intravenous thrombolysis in clinical practice.