A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

January 19, 2017

Primary Completion Date

October 18, 2021

Study Completion Date

October 18, 2021

Conditions
Thrombosis
Interventions
DRUG

Apixaban

Specified dose on specified days

DRUG

Vitamin K Antagonist (VKA)

Specified dose on specified days

DRUG

Low Molecular Weight Heparin (LMWH)

Specified dose on specified days

Trial Locations (46)

0

Local Institution - 0047, Petah Tikva

1090

Local Institution - 0001, Vienna

1426

Local Institution, CABA

3052

Local Institution - 0030, Parkville

14080

Local Institution - 0016, Mexico City

19104

Childrens Hospital Of Philadelphia, Philadelphia

20097

Local Institution - 0027, Milan

20246

Local Institution - 0004, Hamburg

28007

Local Institution, Madrid

28046

Local Institution - 0048, Madrid

29425

Local Institution - 0012, Charleston

30322

Childrens Healthcare Of Atlanta, Atlanta

37000

Local Institution - 0044, León

40138

Local Institution - 0028, Bologna

45229

Local Institution - 0006, Cincinnati

46202

Local Institution - 0008, Indianapolis

48109

Local Institution - 0013, Ann Arbor

52620

Local Institution - 0046, Tel Litwinsky

64108

Childrens Mercy Hospital, Kansas City

79106

Local Institution - 0002, Freiburg im Breisgau

80045

Children'S Hospital Colorado, Aurora

80636

Local Institution - 0003, München

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Children'S Hospital, Phoenix

98105

Local Institution - 0055, Seattle

420012

Local Institution, Kazan'

620134

Local Institution - 0062, Yekaterinburg

630055

Local Institution - 0057, Novosibirsk

650002

Local Institution, Kemerovo

92093-0641

University Of California San Diego, La Jolla

02115

Local Institution - 0009, Boston

77030-2399

Local Institution - 0011, Houston

80250-060

Local Institution - 0022, Curitiba

90620-001

Instituto De Cardiologia Do Rio Grande Do Sul, Porto Alegre

13060-080

Local Institution - 0020, Campinas

01227-200

Instituto de Pesquisa PENSI, São Paulo

04024-002

Universidade Federal De Sao Paulo, São Paulo

M5G 1X8

Local Institution - 0015, Toronto

00029

Local Institution - 0031, HUS

00165

Local Institution - 0026, Rome

04530

Local Institution - 0018, Mexico City

06720

Local Institution - 0019, Mexico City

08950

Local Institution - 0049, Barcelona

LE3 9QP

Local Institution - 0040, Leicester

BS2 8BJ

Local Institution - 0042, Bristol

M13 9WL

Local Institution, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pediatric Heart Network

OTHER

collaborator

Pfizer

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY