NCT01747746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

November 30, 2012

Last Update Submit

February 2, 2015

Conditions

Atrial FibrillationStrokeThrombo-embolismBleeding

Keywords

RivaroxabanWarfarinAnticoagulationStrokeThrombo-embolismBleedingAtrial FibrillationCardioversion

Outcome Measures

Primary Outcomes (1)

  • Thrombosis

    Number of cerebrovascular accidents, thrombus and embolism

    30 days

Secondary Outcomes (3)

  • Mortality

    30 days

  • Hospitalizations

    30 days

  • Bleeding

    30 days

Study Arms (2)

Rivaroxaban

ACTIVE COMPARATOR

Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days

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

Drug: Warfarin and Enoxaparin

Interventions

RivaroxabanDRUG

Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin

Also known as: Xarelto
Rivaroxaban
Warfarin and EnoxaparinDRUG

Historical Control

Also known as: Coumadin
Warfarin and Enoxaparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-valvular atrial fibrillation requiring electrical cardioversion o Atrial fibrillation of unknown duration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cook County Hospital

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Atrial FibrillationStrokeHemorrhage

Interventions

RivaroxabanWarfarinEnoxaparin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Pete Antonopoulos, PharmD

    Cook County Hospital

    PRINCIPAL INVESTIGATOR

  • Asinul Ansari, MD

    Cook County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist- Principal Investigator

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 12, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

US(1)