- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747746
Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study (ARC)
February 2, 2015 updated by: Pete Antonopoulos, John H. Stroger Hospital
Anticoagulation With Rivaroxaban in Post Cardioversion Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Cook County Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rivaroxaban
Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days
|
Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
Other Names:
|
Other: Warfarin and Enoxaparin
Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control
|
Historical Control
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombosis
Time Frame: 30 days
|
Number of cerebrovascular accidents, thrombus and embolism
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
Monitor the 30 day mortality rate
|
30 days
|
Hospitalizations
Time Frame: 30 days
|
Hospitalizations for thrombus or adverse events
|
30 days
|
Bleeding
Time Frame: 30 days
|
The incidence of major and minor bleeding (as defined under 'safety measures')
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pete Antonopoulos, PharmD, Cook County Hospital
- Principal Investigator: Asinul Ansari, MD, Cook County Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 30, 2012
First Submitted That Met QC Criteria
December 11, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Arrhythmias, Cardiac
- Embolism
- Atrial Fibrillation
- Hemorrhage
- Thromboembolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Enoxaparin
- Warfarin
Other Study ID Numbers
- 12-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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