Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Anticoagulation With Rivaroxaban in Post Cardioversion Patients

Conditions
-----------------
Atrial Fibrillation, Stroke, Thrombo-embolism, Bleeding

Intervention / Treatment
-----------------
* Drug: Rivaroxaban
* Drug: Warfarin and Enoxaparin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rivaroxaban<br>Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days | Drug: Rivaroxaban<br>* Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin<br>* Other names: Xarelto;|
| Other: Warfarin and Enoxaparin<br>Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control | Drug: Warfarin and Enoxaparin<br>* Historical Control<br>* Other names: Coumadin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Number of cerebrovascular accidents, thrombus and embolism | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Monitor the 30 day mortality rate | 30 days | 
| Hospitalizations | Hospitalizations for thrombus or adverse events | 30 days | 
| Bleeding | The incidence of major and minor bleeding (as defined under 'safety measures') | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion