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

Primary Purpose

Atrial Fibrillation, Stroke, Thrombo-embolism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rivaroxaban
Warfarin and Enoxaparin
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cook County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Rivaroxaban

Warfarin and Enoxaparin

Arm Description

Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days

Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control

Outcomes

Primary Outcome Measures

Thrombosis
Number of cerebrovascular accidents, thrombus and embolism

Secondary Outcome Measures

Mortality
Monitor the 30 day mortality rate
Hospitalizations
Hospitalizations for thrombus or adverse events
Bleeding
The incidence of major and minor bleeding (as defined under 'safety measures')

Full Information

First Posted
November 30, 2012
Last Updated
February 2, 2015
Sponsor
Cook County Health
Collaborators
Cook County Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01747746
Brief Title
Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study
Acronym
ARC
Official Title
Anticoagulation With Rivaroxaban in Post Cardioversion Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
Collaborators
Cook County Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke, Thrombo-embolism, Bleeding
Keywords
Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Active Comparator
Arm Description
Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days
Arm Title
Warfarin and Enoxaparin
Arm Type
Other
Arm Description
Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Other Intervention Name(s)
Xarelto
Intervention Description
Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
Intervention Type
Drug
Intervention Name(s)
Warfarin and Enoxaparin
Other Intervention Name(s)
Coumadin
Intervention Description
Historical Control
Primary Outcome Measure Information:
Title
Thrombosis
Description
Number of cerebrovascular accidents, thrombus and embolism
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Monitor the 30 day mortality rate
Time Frame
30 days
Title
Hospitalizations
Description
Hospitalizations for thrombus or adverse events
Time Frame
30 days
Title
Bleeding
Description
The incidence of major and minor bleeding (as defined under 'safety measures')
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete Antonopoulos, PharmD
Organizational Affiliation
Cook County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asinul Ansari, MD
Organizational Affiliation
Cook County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cook County Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

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