Trial Condition(s):
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)
16320
Not Available
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.
- 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
Locations | Status | |
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Locations MHAT National Cardiology Hospital EAD Sofia, Bulgaria, 1309 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Multiprofile Hospital for Activ Treatment Plovdiv Plovdiv, Bulgaria, 4000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik St. Georg Hamburg, Germany, 20099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04289 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Saint Antoine - Paris PARIS, France, 75571 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de Rangueil - Toulouse TOULOUSE cedex, France, 31059 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Henri Mondor - Créteil CRETEIL, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego Lodz, Poland, 91-347 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny im. J. Dietla Krakow, Poland, 31-121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-954 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen Warszawa, Poland, 02-005 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centralny Szpital Kliniczny MSW w Warszawie Warszawa, Poland, 02-507 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej Wroclaw, Poland, 50-420 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit Istanbul, Turkey, 34846 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Mehmet Akif Ersoy Thor. & Card. Surg. Ed. & R. Hosp Istanbul, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marmara University Medical Faculty Istanbul, Turkey, 34662 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ondokuz Mayis Universitesi Tip Fakultesi Samsun, Turkey, 55139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Hospital N 4 Moscow, Russia, 115093 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FGBU Russian Cardiology Research & Prod Complex of MoH Moscow, Russia, 121552 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Clinical Hospital Odesa, Ukraine, 65025 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Cardiology AMS Kiev, Ukraine, 03680 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FGBU Federal Center of Heart, Blood & Endocr. VA Almazov MoH St. Petersburg, Russia, 194156 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MUZ “City Clinical Hospital #12” Saratov, Russia, 410039 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser Uzhhorod, Ukraine, 88000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMS Donetsk, Ukraine, 83045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MHAT "Sveta Anna" Sofia, Bulgaria, 1750 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University n.a. Pirogov Moscow, Russia, 117997 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
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