Daily Pharmacy News

Get your free subscription started now. Just enter your email address below.

Argatroban Plus I.V. Alteplase & Neurologic Function in Acute Ischemic Stroke

Compared with argatroban alone in patients with acute ischemic stroke (AIS), argatroban plus intravenous alteplase did not significantly improve the likelihood of excellent functional outcome at 90 days, according to results of the ARAIS randomized trial. The use of the drug combination also did not affect early functional outcomes or early neurologic deterioration at 48 hours.

Conducted at 50 Chinese hospitals, the open-label, blinded endpoint randomized clinical trial included 808 patients with AIS in 2019–21, with follow-up through Jan. 2022. Eligible patients were randomized within 4.5 hours of symptom onset to argatroban plus alteplase or alteplase alone. The primary endpoint was excellent functional outcome at 90 days.

“Among 817 eligible patients with AIS who were randomized (median [IQR] age, 65 [57-71] years; 238 [29.1%] women; median [IQR] National Institutes of Health Stroke Scale score, 9 [7-12]), 760 (93.0%) completed the trial,” the authors report. “At 90 days, 210 of 329 participants (63.8%) in the argatroban plus alteplase group vs 238 of 367 (64.9%) in the alteplase alone group had an excellent functional outcome (risk difference, −1.0% [95% CI, −8.1% to 6.1%]; risk ratio, 0.98 [95% CI, 0.88-1.10]; P = .78). The percentages of participants with symptomatic intracranial hemorrhage, parenchymal hematoma type 2, and major systemic bleeding were 2.1% (8/383), 2.3% (9/383), and 0.3% (1/383), respectively, in the argatroban plus alteplase group and 1.8% (7/397), 2.5% (10/397), and 0.5% (2/397), respectively, in the alteplase alone group.”

Visual abstract available.

Source: JAMA