- Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
- Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
- Aspirin Drug
Other Names: Aspirin at bedtime Intervention Desc: Aspirin 81 mg by mouth once daily. ARM 1: Kind: Experimental Label: Active control: Aspirin Description: Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
- Apixaban Drug
Other Names: BMS-562247 Intervention Desc: 5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose). ARM 1: Kind: Experimental Label: Active agent: Apixaban Description: Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of recurrent stroke||4 years|
|Secondary||Incidence of recurrent ischemic stroke or systemic embolism||Up to 4 years|
|Secondary||Incidence of recurrent stroke of any type plus death from any cause||Up to 4 years|
|Secondary||Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke).||Up to 4 years|
|Secondary||Incidence of major hemorrhage other than intracranial hemorrhage||Up to 4 years|
|Secondary||Incidence of death from any cause||Up to 4 years|