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CompletedNCT01839357X-TRAUpdated Jul 25, 2016

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

A Phase 3 interventional study of Rivaroxaban (Xarelto, BAY59-7939) in Atrial Fibrillation, sponsored by Bayer. Completed at 31 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-25.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation

Keywords

  • Rivaroxaban
  • Oral anticoagulant
  • Nonvalvular atrial fibrillation
  • Left atrial thrombus
  • Transesophageal echocardiography
  • Thrombus resolution
  • Stroke
  • Thromboembolism
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 60 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Rivaroxaban

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

  • DrugRivaroxaban (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.

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What researchers measure

Primary outcomes

  1. The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatment

    Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography

    Time frame: After 6 weeks

Secondary outcomes

  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

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Study locations

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

Publications

  • Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6. PubMed 25819852 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01839357
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Aug 2013
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Jul 25, 2016

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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