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)

July 22, 2016 updated by: Bayer

An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
      • Sofia, Bulgaria, 1309
      • Sofia, Bulgaria, 1750
      • Varna, Bulgaria, 9010
  • France
      • Creteil, France, 94010
      • Marseille, France, 13005
      • Paris, France, 75571
      • TOULOUSE cedex, France, 31059
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20099
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
  • Poland
      • Krakow, Poland, 31-121
      • Lodz, Poland, 91-347
      • Lublin, Poland, 20-954
      • Warszawa, Poland, 02-507
      • Warszawa, Poland, 02-005
      • Wroclaw, Poland, 50-420
  • Russian Federation
      • Moscow, Russian Federation, 121552
      • Moscow, Russian Federation, 117997
      • Moscow, Russian Federation, 115093
      • Saratov, Russian Federation, 410039
      • St. Petersburg, Russian Federation, 194156
  • Turkey
      • Istanbul, Turkey
      • Istanbul, Turkey, 34846
      • Istanbul, Turkey, 34662
      • Samsun, Turkey, 55139
  • Ukraine
      • Donetsk, Ukraine, 83045
      • Kiev, Ukraine, 03680
      • Odesa, Ukraine, 65025
      • Uzhhorod, Ukraine, 88000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women aged >/= 18 years
  • Hemodynamically stable nonvalvular AF or atrial flutter
  • LA/LAA thrombus documented at baseline by transesophageal echocardiography (TEE) up to 72 hours prior to start of study medication
  • vitamin K antagonist(s) (VKA)/ new oral anticoagulant(s) (NOAC)-naïve or untreated within 1 month prior to signing of the informed consent form
  • VKA pretreated but under ineffective INR levels(<2.0,documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
  • Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

  • Transient Ischemic Attack within 3 days prior to study inclusion
  • Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
  • Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
  • Acute myocardial infarction within the last 14 days prior to study inclusion
  • Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus
  • Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
  • Concomitant drugs/therapies: Indication for anticoagulant therapy for a condition other than nonvalvular AF or atrial flutter (eg, venous thromboembolism). Concomitant use of anticoagulant drugs, including VKA, or factor IIa or factor Xa inhibitors. Chronic aspirin therapy >100 mg or dual antiplatelet therapy. Concomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents-ketoconazole, itraconazole, voriconazole, and posaconazole-if used systemically
  • Concomitant conditions: Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. Hypersensitivity to investigational treatment. Calculated creatinine clearance (CrCl) < 15 mL/minute at the screening visit. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk. Any severe condition that would limit life expectancy to less than 3 months (eg, advanced malignancy, etc.). Planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment TEE. Inability to take oral medication. Ongoing drug addiction or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment
Time Frame: After 6 weeks
Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography
After 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new
Time Frame: After 6 weeks
After 6 weeks
The composite number of stroke and non-central nervous system systemic embolism events
Time Frame: Up to 12 weeks
Up to 12 weeks
The number of all bleeding events
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16320
  • 2012-001062-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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