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AzTrials

Atrial FibrillationPhase 3X-TRANCT01839357

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 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Atrial Fibrillation, run by Bayer at 31 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
31 sitesin 7 countries
Study dates
Aug 2013to Dec 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

31 sites in 7 countries.

31 sites in 7 countries

Poland6 sites

  • Study site

    Krakow, 31-121

  • Study site

    Lodz, 91-347

  • Study site

    Lublin, 20-954

  • Study site

    Warsaw, 02-005

  • Study site

    Warsaw, 02-507

  • Study site

    Wroclaw, 50-420

Other trials in Poland

Russia5 sites

  • Study site

    Moscow, 115093

  • Study site

    Moscow, 117997

  • Study site

    Moscow, 121552

  • Study site

    Saint Petersburg, 194156

  • Study site

    Saratov, 410039

Other trials in Russia

Bulgaria4 sites

  • Study site

    Plovdiv, 4000

  • Study site

    Sofia, 1309

  • Study site

    Sofia, 1750

  • Study site

    Varna, 9010

Other trials in Bulgaria

France4 sites

  • Study site

    Créteil, 94010

  • Study site

    Marseille, 13005

  • Study site

    Paris, 75571

  • Study site

    Toulouse, 31059

Other trials in France

Germany4 sites

  • Study site

    Berlin, State of Berlin, 13353

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20099

  • Study site

    Leipzig, Saxony, 04289

Other trials in Germany

Turkey (Türkiye)4 sites

  • Study site

    Istanbul, 34662

  • Study site

    Istanbul, 34846

  • Study site

    Istanbul

  • Study site

    Samsun, 55139

Other trials in Turkey (Türkiye)

Ukraine4 sites

  • Study site

    Donetsk, 83045

  • Study site

    Kiev, 03680

  • Study site

    Odesa, 65025

  • Study site

    Uzhhorod, 88000

Other trials in Ukraine

About this study

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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939)
Keywords
Rivaroxaban, Oral anticoagulant, Nonvalvular atrial fibrillation, Left atrial thrombus, Transesophageal echocardiography, Thrombus resolution, Stroke, Thromboembolism
Medical subject headings
Atrial Fibrillation, Stroke, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    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.

Study groups in NCT01839357
Study groupRoleWhat they receive
RivaroxabanExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After 6 weeks

Secondary outcomes (3)

  1. Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new

    Measured: After 6 weeks

  2. The composite number of stroke and non-central nervous system systemic embolism events

    Measured: Up to 12 weeks

  3. The number of all bleeding events

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839357
Sponsor's protocol ID
16320
Other IDs
2012-001062-15
Acronym
X-TRA
Status last verified
Dec 2015
First submitted
22 Apr 2013
Last updated
25 Jul 2016
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Atrial Fibrillation, run by Bayer at 31 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Poland, Russia, Bulgaria, France, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839357, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.

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