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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01839357
First received: April 22, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography


Secondary Outcome Measures:
  • Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new [ Time Frame: After 6 weeks ] [ Designated as safety issue: No ]
  • The composite number of stroke and non-central nervous system systemic embolism events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • The number of all bleeding events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 121552
Moscow, Russian Federation, 117997
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01839357     History of Changes
Other Study ID Numbers: 16320, 2012-001062-15
Study First Received: April 22, 2013
Last Updated: November 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Bulgaria: Bulgarian Drug Agency
Russia: Ministry of Health of Russian Federation
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: State Expert Center Ministry of Health of Ukraine
Turkey: Ethics Committee, Ministry of Health

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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014