Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Anticoagulation With Rivaroxaban in Post Cardioversion Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747746

Acronym

ARC

Enrollment

Registered

2012-12-12

Start date

2012-10-31

Completion date

2014-10-31

Last updated

2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Bleeding, Stroke, Thrombo-embolism

Keywords

Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion

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.

Interventions

DRUGRivaroxaban

Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin

DRUGWarfarin and Enoxaparin

Historical Control

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Thrombosis	30 days	Number of cerebrovascular accidents, thrombus and embolism

Secondary

Measure	Time frame	Description
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')

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026