check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

16320

ClinicalTrials.gov Identifier:

NCT01839357

EudraCT Number:

2012-001062-15

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
60
Trial Dates
August 2013 - December 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
MHAT National Cardiology Hospital EADSofia, 1309, Bulgaria
Terminated
Multiprofile Hospital for Activ Treatment PlovdivPlovdiv, 4000, Bulgaria
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Terminated
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Asklepios Klinik St. GeorgHamburg, 20099, Germany
Terminated
Universitätsklinikum Leipzig AöRLeipzig, 04289, Germany
Terminated
Hopital Saint Antoine - ParisPARIS, 75571, France
Terminated
Hôpital de la Timone - MarseilleMARSEILLE, 13005, France
Terminated
Hôpital de Rangueil - ToulouseTOULOUSE cedex, 31059, France
Completed
Hôpital Henri Mondor - CréteilCRETEIL, 94010, France
Completed
Wojewodzki Specjalistyczny Szpital im. dr Wl. BieganskiegoLodz, 91-347, Poland
Completed
Szpital Specjalistyczny im. J. DietlaKrakow, 31-121, Poland
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-954, Poland
Terminated
Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia ObrazenWarszawa, 02-005, Poland
Terminated
Centralny Szpital Kliniczny MSW w WarszawieWarszawa, 02-507, Poland
Completed
Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny RatunkowejWroclaw, 50-420, Poland
Completed
Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitIstanbul, 34846, Turkey
Completed
Istanbul Mehmet Akif Ersoy Thor. & Card. Surg. Ed. & R. HospIstanbul, Turkey
Completed
Marmara University Medical FacultyIstanbul, 34662, Turkey
Completed
Ondokuz Mayis Universitesi Tip FakultesiSamsun, 55139, Turkey
Terminated
Municipal Hospital N 4Moscow, 115093, Russia
Completed
FGBU Russian Cardiology Research & Prod Complex of MoHMoscow, 121552, Russia
Terminated
Regional Clinical HospitalOdesa, 65025, Ukraine
Completed
Institute of Cardiology AMSKiev, 03680, Ukraine
Terminated
FGBU Federal Center of Heart, Blood & Endocr. VA Almazov MoHSt. Petersburg, 194156, Russia
Terminated
MUZ “City Clinical Hospital #12”Saratov, 410039, Russia
Completed
Zakarpatsky Oblasnyi Kardiologichnyi DyspanserUzhhorod, 88000, Ukraine
Completed
Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMSDonetsk, 83045, Ukraine
Terminated
MHAT "Sveta Anna"Sofia, 1750, Bulgaria
Terminated
University n.a. PirogovMoscow, 117997, Russia

Primary Outcome

  • 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
    date_rangeTime Frame:
    After 6 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or new
    date_rangeTime Frame:
    After 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The composite number of stroke and non-central nervous system systemic embolism events
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The number of all bleeding events
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results based on ICH-E3 format.