ARAMIS Clinical Trial Demonstrates the Noninferiority of Dual Antiplatelet Therapy Compared with Intravenous Activase in Patients with Minor Nondisabling Acute Ischemic Stroke

Results of the ARAMIS clinical trial (NCT03661411) demonstrated the noninferior efficacy of dual antiplatelet therapy (DAPT) compared with intravenous Activase (alteplase; Genentech, South San Francisco, CA) in patients with minor nondisabling acute ischemic stroke treated within 4.5 hours of symptom onset. This study was published in a recent issue of JAMA.

The phase 4, multicenter, randomized, open-label, blinded end point assessment study took place from October 2018 to July 2022 across 38 hospitals in China and included 760 adult participants who had an acute ischemic stroke (confirmed by computed tomography or MRI) with a National Institutes of Health Stroke Scale (NIHSS) score less than or equal to 5, with less than or equal to 1 point on several single-item scores, and a score of 0 in the consciousness item at the time of randomization. Participants were randomly assigned to receive DAPT (300 mg of clopidogrel on the first day, followed by 75 mg per day for 12 [±2] days; 100 mg of aspirin on the first day, followed by 100 mg daily for 12 [±2] days; and single antiplatelet therapy or DAPT based on guidelines until 90 days; n = 393), or intravenous Activase (0.9 mg/kg [10% as a bolus, 90% infused over 1 hour] to a maximum of 90 mg, followed by guideline-based antiplatelet treatment beginning 24 hours after intravenous thrombolysis; n = 367).

At 90 days, 93.8% of patients in the DAPT group and 91.4% in the Activase group had an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 or 1 (risk difference, 2.3% [95% CI, −1.5% to 6.2%]; crude relative risk, 1.38 [95% CI, 0.81-2.32]). Rates of severe intracranial hemorrhage (sICH) and other bleeding events were lower in the DAPT group (sICH [0.3%]; other bleeding events [1.6%]) compared with the Activase group (sICH [0.9%], other bleeding events [5.4%]).

A possible limitation to this study is the high crossover rate (20.4%) of participants who switched treatments (from Activase to DAPT or vice versa) during the trial. Additionally, the exclusion of patients with possible cardioembolic stroke and the lower percentage of women (31%) enrolled in this trial may influence the generalizability of the findings from this study.