Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Phase 4

Completed

• Conditions: Bleeding; Atrial Fibrillation; Stroke; Thrombo-embolism
• Interventions: Drug: Warfarin and Enoxaparin; Drug: Rivaroxaban

• Registration Number: NCT01747746
• Lead Sponsor: Cook County Health

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin and Enoxaparin	Warfarin and Enoxaparin	Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control
Rivaroxaban	Rivaroxaban	Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days

Primary Outcome Measures

Name	Time	Method
Thrombosis	30 days	Number of cerebrovascular accidents, thrombus and embolism

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days	Monitor the 30 day mortality rate
Hospitalizations	30 days	Hospitalizations for thrombus or adverse events
Bleeding	30 days	The incidence of major and minor bleeding (as defined under 'safety measures')

Trial Locations

Locations (1)

Cook County Hospital; 🇺🇸 Chicago, Illinois, United States