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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)

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ClinicalTrials.gov Identifier: NCT01839357
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Primary Completion Date : November 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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


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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839357


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
Bonn, Nordrhein-Westfalen, Germany, 53105
Leipzig, Sachsen, Germany, 04289
Berlin, Germany, 13353
Hamburg, Germany, 20099
Poland
Krakow, Poland, 31-121
Lodz, Poland, 91-347
Lublin, Poland, 20-954
Warszawa, Poland, 02-005
Warszawa, Poland, 02-507
Wroclaw, Poland, 50-420
Russian Federation
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 117997
Moscow, Russian Federation, 121552
Saratov, Russian Federation, 410039
St. Petersburg, Russian Federation, 194156
Turkey
Istanbul, Turkey, 34662
Istanbul, Turkey, 34846
Istanbul, Turkey
Samsun, Turkey, 55139
Ukraine
Donetsk, Ukraine, 83045
Kiev, Ukraine, 03680
Odesa, Ukraine, 65025
Uzhhorod, Ukraine, 88000
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01839357     History of Changes
Other Study ID Numbers: 16320
2012-001062-15 ( EudraCT Number )
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: December 2015

Keywords provided by Bayer:
Rivaroxaban
Oral anticoagulant
Nonvalvular atrial fibrillation
Left atrial thrombus
Transesophageal echocardiography
Thrombus resolution
Stroke
Thromboembolism

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants