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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

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ClinicalTrials.gov Identifier: NCT02981472
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Pediatric Heart Network
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Thrombosis Drug: Apixaban Drug: Vitamin K Antagonist (VKA) Drug: Low Molecular Weight Heparin (LMWH) Phase 2

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Study Type : Interventional  (Clinical Trial)
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 4, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apixaban Drug: Apixaban
0.4mg/m solution, 0.5mg and 5 mg tablet
Other Name: Eliquis

Active Comparator: LMWH/VKA Drug: Vitamin K Antagonist (VKA)
1, 2.5, and 5 mg
Other Name: Warfarin

Drug: Low Molecular Weight Heparin (LMWH)
100mg/mL
Other Name: Enoxaparin




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: 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 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 ]


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Ages Eligible for Study:   34 Weeks to 17 Years   (Child)
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, 34 weeks adjusted gestational age to < 18 years of age
  • 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 patients 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]

Exclusion Criteria:

  • Recent thromboembolic events less than 6 months prior to enrollment
  • 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 inherited or acquired thrombotic disorders (Antiphoshpholipid syndrome (APS)).

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981472


Contacts
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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 #.

  Show 55 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Pediatric Heart Network
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02981472     History of Changes
Other Study ID Numbers: CV185-362
2016-001247-39 ( EudraCT Number )
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamins
Vitamin K
Heart Diseases
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Apixaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifibrinolytic Agents
Hemostatics
Coagulants