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Completed

NCT Number: NCT01747746

Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thrombo-embolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cook County Hospital

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin

Other names: Xarelto

Warfarin and Enoxaparin

Drug

Historical Control

Other names: Coumadin

Primary outcomes

  1. Thrombosis

    Time frame: 30 days

    Number of cerebrovascular accidents, thrombus and embolism

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    Monitor the 30 day mortality rate

  2. Hospitalizations

    Time frame: 30 days

    Hospitalizations for thrombus or adverse events

  3. Bleeding

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Collaborators

  • Cook County Hospital

Registry information

Official study title

Anticoagulation With Rivaroxaban in Post Cardioversion Patients

Acronym: ARC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2012
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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