Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

May 15, 2018

Primary Completion Date

December 3, 2021

Study Completion Date

December 3, 2021

Conditions
Cardiac Disease
Interventions
DRUG

Edoxaban

Edoxaban 15 mg or 30 mg tablets for participants 12 to \<18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration

DRUG

Standard of Care (SOC)

Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen

Trial Locations (48)

1096

Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Budapest

4020

Kepler Universitätsklinikum Med Campus IV, Linz

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

10000

University Hospital Center Zagreb, Zagreb

11562

Kasr Elainy School of Medicine, Abo Elreesh Hospital (Japanese Hospital), Ali Basha Ibrahim ST Faculty of Medicine Cairo University, Cairo

11566

Ain Shams University Hospital, Cairo

21000

Vynnitsa Regional Children Clinical Hospital Policlinic Dept, Vinnytsia

21131

Alexandria Clinical Research Center, Faculty of Medicine, Alexandria

22903

University of Virginia Health System, Charlottesville

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27834

East Carolina Heart Institute @ ECU, Greenville

28204

Novant Health Heart and Vascular institute, Charlotte

31059

Hôpital Des Enfants, Bâtiment Modulaire, Toulouse

32610

University of Florida College of Medicine, Gainesville

34093

Istanbul University Istanbul Medical Faculty, Istanbul

34295

Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital, Montpellier

35040

Ege University Faculty of Medicine Department of Child Health and Diseases, Izmir

35210

Izmir-Dr. Behçet Uz. Pediatric Diseases and Surgery Training and Research Hospital- Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi, Izmir

35233

University of Alabama at Birmingham, Birmingham

38039

Erciyes University Medical Faculty, Department of Children Hospital, Edirne

41522

Suez Canal University Hospital, Ismailia

44519

Zagazig University Hospital, Zagazig

49100

Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine, Dnipro

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

60612

Rush University Medical Center, Chicago

61093

Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University, Kharkiv

70121

Ochsner Medical Center, New Orleans

73104

OU Health Sciences Center, Oklahoma City

75015

Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes, Paris

85202

Cardon Childrens Medical Center, Mesa

90048

Cedars Sinai Medical Center (ECG), Los Angeles

94158

University of California-San Francisco Department of Pediatrics - Hematology/Oncology, San Francisco

98105

Seattle Children's Research Institute, Seattle

166830

Hotel Dieu de France Hospital, Beirut

395002

Nirmal Hospital Private Limited, Surat

700017

Institute of Child Health, Kolkata

5265601

Sheba Medical Center, Ramat Gan

8410101

Soroka University Medical Center, Beersheba

9112001

Hadassah University Hospital - Ein Kerem, Jerusalem

L8N 3Z5

McMaster Children's Hospital, Hamilton

H3T 1C5

CHU Sainte-Justine, Montreal

H9H 4Y6

McGill University Health Centre/Glen Site/Montreal Children's Hospital, Pierrefonds

11-0236

Children's Heart Centre at the American University of Beirut Medical Center, Beirut

08035

Hospital Universitari Vall d'Hebron, Barcelona

06100

Hacettepe University Medical Faculty, Ankara

SW3 6HP

Royal Brompton Hospital, London

LE3 9QP

Glenfield Hospital, Leicester

G51 4TF

Ward 2B, Royal Hospital for Children, Glasgow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT03395639 - Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease | Biotech Hunter | Biotech Hunter