Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by John H. Stroger Hospital
Sponsor:
Collaborator:
Cook County Hospital
Information provided by (Responsible Party):
Pete Antonopoulos, John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01747746
First received: November 30, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Stroke
Thrombo-embolism
Bleeding
Drug: Rivaroxaban
Drug: Warfarin and Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anticoagulation With Rivaroxaban in Post Cardioversion Patients

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of cerebrovascular accidents, thrombus and embolism


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Monitor the 30 day mortality rate

  • Hospitalizations [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Hospitalizations for thrombus or adverse events

  • Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The incidence of major and minor bleeding (as defined under 'safety measures')


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rivaroxaban
Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days
Drug: Rivaroxaban
Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
Other Name: Xarelto
Warfarin and Enoxaparin
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
Historical Control
Other Name: Coumadin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747746

Contacts
Contact: Pete Antonopoulos, PharmD 312-864-5726 1panton@gmail.com

Locations
United States, Illinois
Cook County Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Pete Antonopoulos, PharmD    312-864-5726    1panton@gmail.com   
Principal Investigator: Pete Antonopoulos, PharmD         
Principal Investigator: Asimul Ansari, MD         
Sub-Investigator: Dan Ng, PharmD         
Sponsors and Collaborators
John H. Stroger Hospital
Cook County Hospital
Investigators
Principal Investigator: Pete Antonopoulos, PharmD Cook County Hospital
Principal Investigator: Asinul Ansari, MD Cook County Hospital
  More Information

No publications provided

Responsible Party: Pete Antonopoulos, Clinical Pharmacist- Principal Investigator, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT01747746     History of Changes
Other Study ID Numbers: 12-139
Study First Received: November 30, 2012
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Rivaroxaban
Warfarin
Anticoagulation
Stroke
Thrombo-embolism
Bleeding
Atrial Fibrillation
Cardioversion

Additional relevant MeSH terms:
Warfarin
Atrial Fibrillation
Embolism
Hemorrhage
Stroke
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thrombosis
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014