Hong KS, et al. - Researchers planned this study to examine whether rivaroxaban or warfarin sodium was safer and more effective for preventing early recurrent stroke in patients with atrial fibrillation (AF)-related acute ischemic stroke. Rivaroxaban and warfarin had comparable safety and efficacy in mild AF-related acute ischemic stroke.

• From April 28, 2014, to December 7, 2015, the researchers designed a randomized, multicenter, open-label, blinded endpoint evaluation, comparative phase 2 trial.
• They conducted this study at 14 academic medical centers in South Korea among patients with mild AF-related stroke within the previous 5 days who were deemed suitable for early anticoagulation.
• They performed the analysis on a modified intent-to-treat basis.
• They randomized participants 1:1 to receive rivaroxaban, 10 mg/d for 5 days followed by 15 or 20 mg/d, or warfarin with a target international normalized ratio of 2.0-3.0, for 4 weeks.
• The composite of the new ischemic lesion or new intracranial hemorrhage seen on results of magnetic resonance imaging at 4 weeks was the primary endpoint.
• They performed the primary analysis in patients who received at least 1 dose of study medications and completed follow-up magnetic resonance imaging.
• Individual components of the primary endpoint and hospitalization length were included as key secondary endpoints.

• The researchers randomized 195 patients.
• Out of them, 183 individuals (76 women and 107 men; mean [SD] age, 70.4 [10.4] years) completed magnetic resonance imaging follow-up and were included in the primary end point analysis.
• No differences were observed in the primary end point (47 [49.5%] vs 48 [54.5%]; relative risk, 0.91; 95% CI, 0.69-1.20; P = .49) or its individual components (new ischemic lesion: 28 [29.5%] vs 31 of 87 [35.6%]; relative risk, 0.83; 95% CI, 0.54-1.26; P = .38; new intracranial hemorrhage: 30 [31.6%] vs 25 of 87 [28.7%]; relative risk, 1.10; 95% CI, 0.70-1.71; P = .68) in the rivaroxaban group (n = 95) and warfarin group (n = 88).
• Each group had 1 clinical ischemic stroke.
• All new intracranial hemorrhages were asymptomatic hemorrhagic transformations.
• With rivaroxaban, hospitalization length was reduced compared with warfarin (median, 4.0 days [interquartile range, 2.0-6.0 days] vs 6.0 days [interquartile range, 4.0-8.0]; P < .001).