Dual antiplatelet therapy (DAPT) was noninferior to intravenous thrombolysis with alteplase in a trial of patients with minor nondisabling acute ischemic stroke presenting within 4.5 hours of symptom onset, researchers report. Functional outcome was excellent at 90 days in more than 90 percent of participants on each intervention.
At 38 hospitals in China, the open-label, blinded endpoint, noninferiority clinical trial randomized 760 patients with acute minor nondisabling stroke within 4.5 hours of symptom onset to clopidogrel 300 mg plus aspirin 100 mg on day 1 followed by clopidogrel 75 mg daily plus aspirin 100 mg daily for 12 ± 2 days, with guideline-based antiplatelet treatment until 90 days, or intravenous alteplase group 0.9 mg/kg (maximum dose, 90 mg) followed by guideline-based antiplatelet treatment beginning 24 hours after receipt of alteplase. Based on a primary endpoint of excellent functional outcome (modified Rankin score of 0 or 1 on a 0 to 6 scale) at 90 days, the investigators found: “Among 760 eligible randomized patients (median [IQR] age, 64 [57-71] years; 223 [31.0%] women; median [IQR] [National Institutes of Health Stroke Scale] score, 2 [1-3]), 719 (94.6%) completed the trial. At 90 days, 93.8% of patients (346/369) in the DAPT group and 91.4% (320/350) in the alteplase group had an excellent functional outcome (risk difference, 2.3% [95% CI, −1.5% to 6.2%]; crude relative risk, 1.38 [95% CI, 0.81-2.32]). The unadjusted lower limit of the 1-sided 97.5% CI was −1.5%, which is larger than the −4.5% noninferiority margin (P for noninferiority <.001). Symptomatic intracerebral hemorrhage at 90 days occurred in 1 of 371 participants (0.3%) in the DAPT group and 3 of 351 (0.9%) in the alteplase group.”