Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine that a new drug called "Rivaroxaban®" is effective in preventing patients from forming clots after their heart rhythm has been reset by the cardiologist with an electrical device.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John H. Stroger Hospital
• Collaborator: Cook County Hospital
• Treatments: Enoxaparin; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

• Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration

Exclusion Criteria:

• Patients requiring extended anticoagulation after cardioversion due to concomitant risk factors as defined by CHADS2 score ≥ 1

• Significant renal dysfunction (CrCl <15mL/min)

• Significant hepatic dysfunction (Childs-Pugh Class B or C)

• History of coagulopathy

• Active bleeding

• Hypersensitivity to Rivaroxaban

• Concomitant use of anticoagulants

• Concomitant use of potent CYP3A4/P-gp inhibitors or inducers

• Interventions requiring interruption of therapy

• Pregnancy

• Age <18 y/o

• History of GI Bleed