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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

  • Clinicaltrials.gov identifier

    NCT02981472

  • Recruitment Status

    Recruiting

  • First Posted

    December 5, 2016

  • Last update posted

    October 8, 2020

Study Description

Brief summary:

To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.

  • Condition or Disease:Thrombosis
  • Intervention/Treatment: Drug: Apixaban
    Drug: Vitamin K Antagonist (VKA)
    Drug: Low Molecular Weight Heparin (LMWH)
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
  • Actual Study Start Date: January 2017
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: October 2021

Arms and interventions

Arm Intervention/treatment
Experimental: Apixaban
Drug: Apixaban
Specified dose on specified days
Active Comparator: LMWH/VKA
Drug: Vitamin K Antagonist (VKA)
Specified dose on specified days

Drug: Low Molecular Weight Heparin (LMWH)
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of bleeding events [ Time Frame: 14 months ]
  • Secondary Outcome Measures: 1. Demographic Relationship to Total Body Clearance (CL/F) [ Time Frame: 14 months ]
  • 2. Demographic Relationship to volume of distribution [ Time Frame: 14 months ]
  • 3. Demographic relationship to absorption rate constant [ Time Frame: 14 months ]
  • 4. Plasma Concentration as measured by: Cmax [ Time Frame: 14 months ]
  • 5. Plasma Concentration as measured by: Cmin [ Time Frame: 14 months ]
  • 6. Plasma concentration as measured by: Area under the concentration-time curve in one dosing interval [AUC (TAU)] [ Time Frame: 14 months ]
  • 7. Activity of Factor X [ Time Frame: 14 months ]
  • 8. Activity of Anti-FXa (Anti-factor 10a) [ Time Frame: 14 months ]
  • 9. Incidence of Thrombotic Events [ Time Frame: 14 months ]
  • 10. Patient/proxy reported outcome or quality of life determined by The Pediatric Quality of Life Inventory (PedsQL) generic core and cardiac modules [ Time Frame: 14 months ]
  • 11. Patient/proxy reported outcome or quality of life determined by the Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT©) pediatric quality of life inventory [ Time Frame: 14 months ]
  • 12. Incidence of major bleeding [ Time Frame: 14 months ]
  • 13. Incidence of Clinically relevant non-major bleeding (CRNM) bleeding [ Time Frame: 14 months ]
  • 14. Incidence of all bleeding [ Time Frame: 14 months ]
  • 15. Safety Analysis: Reasons of Drug discontinuation [ Time Frame: 14 months ]
  • 16. Safety Analysis: Incidence of Death [ Time Frame: 14 months ]

Eligibility Criteria

  • Ages Eligible for Study: up to 17 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Males and Females, 28 days to < 18 years of age, inclusive - Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension) - Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis - Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube] - Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization Exclusion Criteria: - Recent thromboembolic events less than 6 months prior to enrollment - Weight < 3 kg - Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment - Artificial heart valves and mechanical heart valves - Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.) - Active bleeding at the time of enrollment - Any major bleeding other than perioperative in the preceding 3 months - Known intracranial congenital vascular malformation or tumor - Confirmed diagnosis of a GI ulcer - Known antiphospholipid syndrome (APS). Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT# and Site #.

Locations

United States, Arizona
Phoenix Children'S Hospital
Phoenix

United States, California
University Of California San Diego
La Jolla

United States, Colorado
Children'S Hospital Colorado
Aurora

United States, Delaware
Local Institution
Wilmington

United States, Georgia
Childrens Healthcare Of Atlanta
Atlanta

United States, Indiana
Riley Hospital For Children
Indianapolis

United States, Massachusetts
Boston Childrens Hospital
Boston

United States, Michigan
University Of Michigan
Ann Arbor

United States, Missouri
Childrens Mercy Hospital
Kansas City

United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati

United States, Pennsylvania
Childrens Hospital Of Philadelphia
Philadelphia

United States, South Carolina
Medical University Of South Carolina
Charleston

United States, Texas
Texas Children'S Hospital
Houston

United States, Utah
Primary Children's Hospital
Salt Lake City

United States, Washington
Seattle Childrens Hospital
Seattle

Argentina, Buenos Aires
Local Institution
Caba

Australia, New South Wales
Local Institution
Westmead

Australia, Victoria
Local Institution
Parkville

Austria
Medical University Of Vienna
Vienna

Brazil, Distrito Federal
Local Institution
Brasilia

Brazil, Parana
Hospital Pequeno Principe
Curitiba

Brazil, Rio Grande Do Sul
Local Institution
Passo Fundo

Brazil, RIO Grande DO SUL
Instituto De Cardiologia Do Rio Grande Do Sul
Porto Alegre

Brazil, SAO Paulo
Instituto de Pesquisa Clinica de Campinas
Campinas

Brazil
Instituto de Pesquisa PENSI
Sao Paulo

Brazil
Local Institution
Sao Paulo

Brazil
Universidade Federal De Sao Paulo
Sao Paulo

Canada, Ontario
Local Institution
Toronto

Finland
Local Institution
Helsinki

France
Local Institution
Marseille

France
Local Institution
Montpellier

France
Local Institution
Paris

France
Local Institution
Pessac

Germany
Universitatsklinikum Freiburg Kinderklinik
Freiburg

Germany
Uni Hamburg-Eppendorf
Hamburg

Germany
Deutsches Herzzentrum Munchen Des Freistaates Bayern
Muenchen

Israel
Local Institution
Petach Tikva

Israel
Local Institution
Tel Hashomer

Italy
Local Institution
Bologna

Italy
Policlinico San Donato
Milano

Italy
Ospedale Bambino Gesu'
Roma

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Guanajuato
Morales Vargas Centro de Investigacion, S.C.
Leon

Russian Federation
Local Institution
Ekaterinburg

Russian Federation
Local Institution
Kazan

Russian Federation
Local Institution
Kemerovo

Russian Federation
Local Institution
Novosibirsk

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

United Kingdom, Leicestershire
Local Institution
Leicester

United Kingdom, Somerset
Local Institution
Bristol

United Kingdom
Local Institution
Manchester

Sponsors and Collaborators

Bristol-Myers Squibb

Pediatric Heart Network

Pfizer

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT02981472 History of Changes
  • Other Study ID Numbers: CV185-362, 2016-001247-39
  • First Posted: December 5, 2016 Key Record Dates
  • Last Update Posted: October 8, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Thrombosis Heart Diseases