Atrial FibrillationPhase 4ARCNCT01747746
Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study
A Phase 4 study testing Rivaroxaban and Warfarin and Enoxaparin in people with Atrial Fibrillation and Stroke, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Stroke, Thrombo-embolism
- What is being tested?
- Rivaroxaban and Warfarin and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Stroke, Thrombo-embolism, Bleeding
- Being tested
- Rivaroxaban, Warfarin and Enoxaparin
- Keywords
- Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion
- Medical subject headings
- Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
Warfarin and EnoxaparinDrug
Also called Coumadin
Historical Control
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Active comparator | Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days Receives: Drug: Rivaroxaban |
| Warfarin and Enoxaparin | Other | Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control Receives: Drug: Warfarin and Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis
Number of cerebrovascular accidents, thrombus and embolism
Measured: 30 days
Secondary outcomes (3)
Mortality
Monitor the 30 day mortality rate
Measured: 30 days
Hospitalizations
Hospitalizations for thrombus or adverse events
Measured: 30 days
Bleeding
The incidence of major and minor bleeding (as defined under 'safety measures')
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Cook County Hospital
- Responsible party
- Principal investigator, Pete Antonopoulos, Cook County Health
- Investigators
- Pete Antonopoulos, PharmD, Principal investigator, Cook County HospitalAsinul Ansari, MD, Principal investigator, Cook County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747746
- Sponsor's protocol ID
- 12-139
- Acronym
- ARC
- Status last verified
- Feb 2015
- First submitted
- 30 Nov 2012
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation With Rivaroxaban in Post Cardioversion Patients
- ClinicalTrials.gov ID
- NCT01747746
- Acronym / sponsor ID
- ARC / 12-139
- Conditions
- Atrial Fibrillation, Stroke, Thrombo-embolism, Bleeding
- Keywords
- Rivaroxaban, Warfarin, Anticoagulation, Stroke, Thrombo-embolism, Bleeding, Atrial Fibrillation, Cardioversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Cook County Hospital
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Active comparator | Drug: RivaroxabanAnticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days |
| Warfarin and Enoxaparin | Other | Drug: Warfarin and EnoxaparinWarfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: XareltoRivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin | Drug | Rivaroxaban |
| Warfarin and EnoxaparinAlso: CoumadinHistorical Control | Drug | Warfarin and Enoxaparin |
Primary outcome
Thrombosis
Time frame: 30 days
Number of cerebrovascular accidents, thrombus and embolism
3 secondary outcomes
Mortality
Time frame: 30 days
Hospitalizations
Time frame: 30 days
Bleeding
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete Antonopoulos, PharmD principal investigator
Cook County Hospital
Asinul Ansari, MD principal investigator
Cook County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and Warfarin and Enoxaparin in people with Atrial Fibrillation and Stroke, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.