Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Cook County Health

Status and phase

Completed

Phase 4

Conditions

Thrombo-embolism

Atrial Fibrillation

Stroke

Bleeding

Treatments

Drug: Warfarin and Enoxaparin

Drug: Rivaroxaban

Study type

Interventional

Funder types

Other

Identifiers

NCT01747746

12-139

Details and patient eligibility

About

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.

Full description

Patient who are electrically cardioverted require 1 month of anticoagulation (blood thinner). Rivaroxaban a Xa-inhibitor has been shown to be non-inferior to Warfarin (Vit K antagonist) the current standard of care in many treatment areas. Rivaroxaban will be compared to Warfarin historical control group studying the safety and efficacy in electrically cardioverted patients.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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