Early tirofiban significantly improved the likelihood of disability-free and functionally independent outcomes in patients with acute ischemic noncardioembolic stroke who receive thrombolysis within 4.5 hours after onset, according to results from the phase 3 ASSET-IT trial, published July 3 in NEJM.

Chunrong Tao, MD, PhD, et al., randomly assigned 832 patients (median age, 69 years; 36% women) from 38 centers in China to receive a 24-hour intravenous (IV) tirofiban infusion (n=414) or placebo (n=418) within 60 minutes following IV thrombolysis. Most patients (75%) received alteplase and 25% received tenecteplase. Treatment times were similar in both groups.

Stroke was caused by large-vessel atherosclerosis (58%), small-vessel occlusion (35%) or was undetermined in 6% of patients; 28% had a history of stroke. All patients had a National Institutes of Health Stroke Scale score between 4 and 25 (mean score of 6) and were ineligible for endovascular thrombectomy.

Results showed that 66% of patients who received tirofiban achieved an excellent functional outcome (defined as modified Rankin Scale score of 0-1) at 90 days, compared with 55% of patients who received placebo (risk ratio [RR], 1.20; p=0.001).

Regarding safety, no between-group difference was seen in 90-day mortality, occurring in about 4% of each group (RR, 1.07). Symptomatic intracranial hemorrhage within 36 hours was low and occurred in seven patients receiving tirofiban vs. none with placebo. The authors suggest the low incidence "may reflect the enrollment of a population with mild stroke deficits and less injured tissue at risk for hemorrhagic transformation." Systemic bleeding occurred in 11 patients receiving tirofiban and six patient receiving placebo.

Tao and colleagues write that overall, "these results should be interpreted with caution because the secondary outcomes, which were not adjusted for multiplicity, varied in their differences of effects, and the results apply only to noncardioembolic strokes that were not eligible for thrombectomy."