Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study "ARC"

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Rivaroxaban Drug
    Intervention Desc: Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Anticoagulation with Rivaroxaban 20 mg daily with dinner for 30 days
    ARM 2: Kind: Experimental
    Label: Warfarin and Enoxaparin Historical Control
    Description: Warfarin and Enoxaparin weight based historic control
  • Warfarin and Enoxaparin Drug
    Other Names: Coumadin
    Intervention Desc: Historical Control
    ARM 1: Kind: Experimental
    Label: Warfarin and Enoxaparin
    Description: Warfarin: 1-10 mg per Nomogram Enoxaparin weight based 1 mg/kg Q12 or 1.5 mg/kg/day Historic control

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Thrombosis 30 days Yes
Primary Bleeding 30 days Yes
Secondary Mortality 30 days Yes
Secondary Hospitalizations 30 days Yes

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