Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Stroke Clinical Trial

— ARC  

Official title:

Anticoagulation With Rivaroxaban in Post Cardioversion Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747746
• Other study ID #: 12-139
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2012
• Last updated: February 2, 2015
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Embolism
• Stroke
• Thrombo-embolism
• Thromboembolism

Intervention

Drug:
• Rivaroxaban
Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
• Warfarin and Enoxaparin
Historical Control

Locations

Country	Name	City	State
United States	Cook County Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
John H. Stroger Hospital	Cook County Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis	Number of cerebrovascular accidents, thrombus and embolism	30 days	Yes
Secondary	Mortality	Monitor the 30 day mortality rate	30 days	Yes
Secondary	Hospitalizations	Hospitalizations for thrombus or adverse events	30 days	Yes
Secondary	Bleeding	The incidence of major and minor bleeding (as defined under 'safety measures')	30 days	Yes