6/28/23, 11:22 PM NAVIGATE Pathway Feedback Search Clinical Topics Home Studies NAVIGATE NAVIGATE Disease Acute ischemic stroke Trial question What is the role of rivaroxaban in secondary stroke prevention in patients with embolic stroke of undetermined source? Study design Multi-center Double blinded RCT Population Characteristics of study participants 38.4% female N = 7213 61.6% male 7213 patients (2777 female, 4432 male) Inclusion criteria: patients with embolic stroke of undetermined source; with patent foramen ovale and without PFO Key exclusion criteria: a history of AF, severely disabling stroke, the presence of or plan to insert an implantable ECG loop recorder, specific indication for chronic anticoagulation or for chronic antiplatelet therapy, or previous non-traumatic intracranial hemorrhage Interventions N=3609 rivaroxaban (15 mg tablet plus placebo-aspirin once daily) N=3604 aspirin (at a dose of 100 mg tablet plus placebo-rivaroxaban once daily) https://web.pathway.md/studies/recSD6Rqxi7X3PQ4y 1/2 6/28/23, 11:22 PM NAVIGATE Pathway Primary outcome Incidence of recurrent ischemic stroke in patients with patent foramen ovale 4.8/100 py 4.8 3.6/100 py 2.6 2.4/100 py 1.2/100 py No significant difference 0.0/100 py Rivaroxaban Aspirin No significant difference in the incidence of recurrent ischemic stroke in patients with patent foramen ovale (2.6 /100 py vs. 4.8 /100 py; HR 0.54, 95% CI 0.22 to 1.36) Secondary outcomes No significant difference in the incidence of recurrent ischemic stroke in patients without PFO (4.9 /100 py vs. 4.6 /100 py; HR 1.06, 95% CI 0.84 to 1.33) Safety outcomes No significant differences in risks of major bleeding in patients with PFO (HR 2.05, 95% CI 0.51- 8.18) and without PFO (HR 2.82, 95% CI 1.69-4.70; p interaction=0.68). Conclusion In patients with embolic stroke of undetermined source; with patent foramen ovale and without PFO, rivaroxaban was not superior to aspirin with respect to the incidence of recurrent ischemic stroke in patients with patent foramen ovale. Reference Kasner SE, Swaminathan B, Lavados P et al. Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial. Lancet Neurol. 2018 Dec;17(12):1053-1060. Open reference URL https://web.pathway.md/studies/recSD6Rqxi7X3PQ4y 2/2