Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study



Status:Completed
Conditions:Atrial Fibrillation, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:October 2012
End Date:October 2014
Contact:Pete Antonopoulos, PharmD
Email:1panton@gmail.com
Phone:312-864-5726

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Trial Summary
Trial Overview
Inclusion Criteria

Anticoagulation With Rivaroxaban in Post Cardioversion Patients

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.

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.

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
We found this trial at
1
site
Cook County Hosp
1900 W Polk St
Chicago, Illinois 60612
?
mi
from
Chicago, IL
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