Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Cook County Health33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Stroke Thrombo-embolism Bleeding

Interventions

RivaroxabanDRUG

Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin

Warfarin and EnoxaparinDRUG

Historical Control

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cook County Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Thrombosis

Number of cerebrovascular accidents, thrombus and embolism

Time frame: 30 days

Secondary Outcomes

Mortality

Monitor the 30 day mortality rate

Time frame: 30 days

Hospitalizations

Hospitalizations for thrombus or adverse events

Time frame: 30 days

Bleeding

The incidence of major and minor bleeding (as defined under 'safety measures')

Time frame: 30 days

Data from ClinicalTrials.gov

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