Dual Antiplatelet Therapy Superior to Aspirin Alone in Reducing Early Neurologic Deterioration in People with Mild-to-Moderate Ischemic Stroke

The use of combination therapy consisting of clopidogrel with aspirin was shown to be superior to aspirin alone in reducing early neurologic deterioration at 7 days for people who experienced a mild-to-moderate ischemic stroke. Clopidogrel with aspirin was also shown to have a similar safety profile to aspirin alone. These results of the ATAMIS clinical trial (NCT02869009), conducted in China, were published in JAMA Neurology.

ATAMIS was a multicenter, prospective, randomized, open-label, controlled trial that assessed the safety and efficacy of dual antiplatelet therapy in comparison to aspirin alone as a treatment for people with acute mild-to-moderate ischemic stroke. The study enrolled 3000 adult participants aged ≥18 years from 60 centers in Northeast China with acute ischemic stroke. Participants were randomized 1:1 to receive either clopidogrel and aspirin (n=1541) or aspirin alone (n=1459). The primary outcome measure of the study was neurologic deterioration at 7 days, which was defined as an increase of ≥2 points per the National Institutes of Health Stroke Scale (NIHSS) from baseline. Superiority of dual antiplatelet therapy compared with aspirin alone was assessed in a modified intention-to-treat population (N=2915), with secondary outcome measures assessing safety based on moderate-to-severe bleeding events.

In terms of results of the modified intention-to-treat analysis:

• In the dual antiplatelet therapy group (n=1502), early neurologic deterioration occurred in 4.8% (n=72) of participants.
• In the aspirin group (n=1413), early neurologic deterioration occurred in 6.7% (n=95) of participants.

The results show that the combination of clopidogrel and aspirin resulted in reduced incidence of early neurologic deterioration among participants (risk difference, -1.9%; 95% CI, -3.6 to -0.2; P=.03). There were a similar number of moderate-to-severe bleeding events across both groups.