Antiplatelet vs. R-tPA for acute mild ischemic stroke: A prospective, random, and open label multi-center study.

RATIONALE

The evidence of intravenous thrombolysis in patients with not clearly disabling minor stroke (low National Institutes of Health Stroke Scale of 0-5) is still insufficient. Recent early terminated PRISMS trial could not provide definitive conclusion, although suggesting the similar functional outcome between alteplase and aspirin groups. Recent two clinical trials provide a definitive evidence for the superiority of dual antiplatelet to mono-antiplatelet in minor stroke. However, the efficacy and safety of dual antiplatelet vs. alteplase in the treatment of acute minor stroke are not known.

AIM

To explore the efficacy and safety of dual antiplatelet with aspirin and clopidogrel vs. alteplase in the treatment of acute minor stroke.

SAMPLE SIZE ESTIMATES

A maximum of 760 subjects are required to test the non-inferiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by age, diabetes, time from onset to treatment, stroke etiology, degree of vascular stenosis, location of index vessel.

METHODS AND DESIGN

ARAMIS is a prospective, randomized, open label, blinded assessment of endpoints (PROBE) and multicenter clinical trial in China. The subjects are randomized to the control arm (intravenous alteplase with standard dose of 0.9 mg/kg, followed by guideline-based treatment 24 h after thrombolysis) or the experiment arm (clopidogrel: loading dose of 300 mg on the first day, followed by 75 mg daily for 10-14 days; aspirin: 100 mg on the first day, followed by 100 mg daily for 10-14 days; after the combination, antiplatelet will be given based on guideline till 90 days).

STUDY OUTCOME

The primary efficacy endpoint is favorable functional outcome, defined as a mRS 0-1 assessed at 90-day post-randomization.