AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke "ARCADIA"

Not yet recruiting

Phase 3 Results N/A

Trial Description

Objectives
- 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.

Detailed Description

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.

Conditions

Interventions

  • Aspirin Drug
    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

Outcomes

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

Sponsors