check_circleStudy Completed
Atrial Fibrillation
Bayer Identifier:
16320
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
60Trial Dates
August 2013 - December 2014Phase
Phase 3Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | MHAT National Cardiology Hospital EAD | Sofia, 1309, Bulgaria |
Terminated | Multiprofile Hospital for Activ Treatment Plovdiv | Plovdiv, 4000, Bulgaria |
Completed | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Completed | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Terminated | Charité Campus Virchow-Klinikum (CVK) | Berlin, 13353, Germany |
Completed | Asklepios Klinik St. Georg | Hamburg, 20099, Germany |
Terminated | Universitätsklinikum Leipzig AöR | Leipzig, 04289, Germany |
Terminated | Hopital Saint Antoine - Paris | PARIS, 75571, France |
Terminated | Hôpital de la Timone - Marseille | MARSEILLE, 13005, France |
Terminated | Hôpital de Rangueil - Toulouse | TOULOUSE cedex, 31059, France |
Completed | Hôpital Henri Mondor - Créteil | CRETEIL, 94010, France |
Completed | Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego | Lodz, 91-347, Poland |
Completed | Szpital Specjalistyczny im. J. Dietla | Krakow, 31-121, Poland |
Completed | Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin, 20-954, Poland |
Terminated | Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen | Warszawa, 02-005, Poland |
Terminated | Centralny Szpital Kliniczny MSW w Warszawie | Warszawa, 02-507, Poland |
Completed | Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej | Wroclaw, 50-420, Poland |
Completed | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit | Istanbul, 34846, Turkey |
Completed | Istanbul Mehmet Akif Ersoy Thor. & Card. Surg. Ed. & R. Hosp | Istanbul, Turkey |
Completed | Marmara University Medical Faculty | Istanbul, 34662, Turkey |
Completed | Ondokuz Mayis Universitesi Tip Fakultesi | Samsun, 55139, Turkey |
Terminated | Municipal Hospital N 4 | Moscow, 115093, Russia |
Completed | FGBU Russian Cardiology Research & Prod Complex of MoH | Moscow, 121552, Russia |
Terminated | Regional Clinical Hospital | Odesa, 65025, Ukraine |
Completed | Institute of Cardiology AMS | Kiev, 03680, Ukraine |
Terminated | FGBU Federal Center of Heart, Blood & Endocr. VA Almazov MoH | St. Petersburg, 194156, Russia |
Terminated | MUZ “City Clinical Hospital #12” | Saratov, 410039, Russia |
Completed | Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser | Uzhhorod, 88000, Ukraine |
Completed | Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMS | Donetsk, 83045, Ukraine |
Terminated | MHAT "Sveta Anna" | Sofia, 1750, Bulgaria |
Terminated | University n.a. Pirogov | Moscow, 117997, Russia |
Primary Outcome
- The percentage of subjects with complete resolution of left atrial or left atrial appendage thrombus at the end of treatmentComplete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiographydate_rangeTime Frame:After 6 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Categories of thrombus outcome in subjects: resolved, reduced, unchanged, enlarged or newdate_rangeTime Frame:After 6 weeksenhanced_encryptionNoSafety Issue:
- The composite number of stroke and non-central nervous system systemic embolism eventsdate_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- The number of all bleeding eventsdate_rangeTime Frame:Up to 12 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1