Exploring the Efficacy of Once Daily Oral Rivaroxaban for Treatment of Thrombus in Left Atrial/Left Atrial Appendage in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter "X-TRA"

Completed

Phase 3 Results N/A

Trial Description

A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: Rivaroxaban 20 mg orally once daily for 6 weeks; subjects with severe to moderate renal impairment (ie, CrCl of 15 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily for 6 weeks in the study.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment After 6 weeks No
Secondary Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new After 6 weeks No
Secondary The composite number of stroke and non-central nervous system systemic embolism events Up to 12 weeks No
Secondary The number of all bleeding events Up to 12 weeks Yes

Sponsors