The ARAMIS trial is designed to evaluate whether dual antiplatelet therapy is noninferior to intravenous alteplase for achieving a favorable functional outcome at 90 days in acute minor stroke.
RCT (n=760)
Open-label
randomized
Yes
Does dual antiplatelet therapy with aspirin and clopidogrel improve favorable functional outcome compared to intravenous alteplase in patients with acute minor stroke?
The ARAMIS trial is designed to evaluate whether dual antiplatelet therapy is non-inferior to intravenous alteplase for achieving favorable functional outcomes in patients with acute minor ischemic stroke.
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.
Wang et al. (2019) conducted an RCT in Acute minor ischemic stroke (n=760). Dual antiplatelet therapy (clopidogrel and aspirin) vs. Intravenous alteplase (0.9 mg/kg) was evaluated on Favorable functional outcome, defined as a mRS 0-1 assessed at 90-day post-randomization. The ARAMIS trial is designed to evaluate whether dual antiplatelet therapy is noninferior to intravenous alteplase for achieving a favorable functional outcome at 90 days in acute minor stroke.