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Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study (ARC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747746
First Posted: December 12, 2012
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cook County Hospital
Information provided by (Responsible Party):
Pete Antonopoulos, John H. Stroger Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Pete Antonopoulos, John H. Stroger Hospital:

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


Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ]
    Monitor the 30 day mortality rate

  • Hospitalizations [ Time Frame: 30 days ]
    Hospitalizations for thrombus or adverse events

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


Enrollment: 33
Study Start Date: October 2012
Study Completion Date: October 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747746


Locations
United States, Illinois
Cook County Hospital
Chicago, Illinois, United States, 60612
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

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
First Submitted: November 30, 2012
First Posted: December 12, 2012
Last Update Posted: February 3, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Atrial Fibrillation
Hemorrhage
Embolism
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Warfarin
Rivaroxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action