NCT01839357

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
7 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 25, 2016

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

April 22, 2013

Last Update Submit

July 22, 2016

Conditions

Atrial Fibrillation

Keywords

RivaroxabanOral anticoagulantNonvalvular atrial fibrillationLeft atrial thrombusTransesophageal echocardiographyThrombus resolutionStrokeThromboembolism

Outcome Measures

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

    After 6 weeks

Secondary Outcomes (3)

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

    After 6 weeks

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

    Up to 12 weeks

  • The number of all bleeding events

    Up to 12 weeks

Study Arms (1)

Rivaroxaban

EXPERIMENTAL
Drug: Rivaroxaban (Xarelto, BAY59-7939)

Interventions

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.

Rivaroxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Unknown Facility

Plovdiv, 4000, Bulgaria

Location

Unknown Facility

Sofia, 1309, Bulgaria

Location

Unknown Facility

Sofia, 1750, Bulgaria

Location

Unknown Facility

Varna, 9010, Bulgaria

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Marseille, 13005, France

Location

Unknown Facility

Paris, 75571, France

Location

Unknown Facility

Toulouse, 31059, France

Location

Unknown Facility

Hamburg, Hamburg, 20099, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Leipzig, Saxony, 04289, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Krakow, 31-121, Poland

Location

Unknown Facility

Lodz, 91-347, Poland

Location

Unknown Facility

Lublin, 20-954, Poland

Location

Unknown Facility

Warsaw, 02-005, Poland

Location

Unknown Facility

Warsaw, 02-507, Poland

Location

Unknown Facility

Wroclaw, 50-420, Poland

Location

Unknown Facility

Moscow, 115093, Russia

Location

Unknown Facility

Moscow, 117997, Russia

Location

Unknown Facility

Moscow, 121552, Russia

Location

Unknown Facility

Saint Petersburg, 194156, Russia

Location

Unknown Facility

Saratov, 410039, Russia

Location

Unknown Facility

Istanbul, 34662, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34846, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, Turkey (Türkiye)

Location

Unknown Facility

Samsun, 55139, Turkey (Türkiye)

Location

Unknown Facility

Donetsk, 83045, Ukraine

Location

Unknown Facility

Kiev, 03680, Ukraine

Location

Unknown Facility

Odesa, 65025, Ukraine

Location

Unknown Facility

Uzhhorod, 88000, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 25819852DERIVED

MeSH Terms

Conditions

Atrial FibrillationStrokeThromboembolism

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

July 25, 2016

Record last verified: 2015-12

Locations

DE(4)BU(4)RU(5)TU(4)FR(4)UA(4)PL(6)