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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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apixaban
Vitamin K Antagonist (VKA)
Low Molecular Weight Heparin (LMWH)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

28 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children'S Hospital
  • University Of California San Diego
  • Children'S Hospital Colorado
  • Childrens Healthcare Of Atlanta
  • Local Institution - 0008
  • Local Institution - 0009
  • Local Institution - 0013
  • Childrens Mercy Hospital
  • Local Institution - 0006
  • Childrens Hospital Of Philadelphia
  • Local Institution - 0012
  • Local Institution - 0011
  • Primary Children's Hospital
  • Local Institution - 0055
  • Local Institution
  • Local Institution - 0030
  • Local Institution - 0001
  • Local Institution - 0022
  • Instituto De Cardiologia Do Rio Grande Do Sul
  • Local Institution - 0020
  • Instituto de Pesquisa PENSI
  • Universidade Federal De Sao Paulo
  • Local Institution - 0015
  • Local Institution - 0031
  • Local Institution - 0002
  • Local Institution - 0004
  • Local Institution - 0003
  • Local Institution - 0047
  • Local Institution - 0046
  • Local Institution - 0026
  • Local Institution - 0028
  • Local Institution - 0027
  • Local Institution - 0018
  • Local Institution - 0019
  • Local Institution - 0016
  • Local Institution - 0044
  • Local Institution - 0062
  • Local Institution
  • Local Institution
  • Local Institution - 0057
  • Local Institution - 0049
  • Local Institution
  • Local Institution - 0048
  • Local Institution - 0040
  • Local Institution - 0042
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

LMWH/VKA

Arm Description

Outcomes

Primary Outcome Measures

Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.

Secondary Outcome Measures

The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis. Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)
The Number of Participants With Adjudicated Major Bleeding
The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding is defined as bleeding that satisfies one or more of the following criteria: fatal bleeding clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS bleeding that requires surgical intervention in an operating suite, including interventional radiology
The Number of Participants With Adjudicated CRNM Bleeding
The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
The Number of Participants With All Adjudicated Bleeding
The number of participants with all adjudicated bleeding events
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
The Number of Participant Deaths in the Study
The number of participant deaths in the study.
Maximum Observed Concentration (Cmax)
Trough Observed Concentration (Cmin)
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Time of Maximum Observed Concentration (Tmax)
Anti-FXa Activity
Anti-FXa Activity was measured to assess participant plasma apixaban levels. 125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.
Chromogenic FX Assay (Apparent FX Level)
Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban. 125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot). Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.

Full Information

First Posted
November 18, 2016
Last Updated
September 29, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Pediatric Heart Network, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02981472
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
October 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pediatric Heart Network, Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Title
LMWH/VKA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Vitamin K Antagonist (VKA)
Other Intervention Name(s)
Warfarin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Low Molecular Weight Heparin (LMWH)
Other Intervention Name(s)
Enoxaparin
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
Description
The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology. CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary Outcome Measure Information:
Title
The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
Description
The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis. Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)
Time Frame
From randomization to 2 days after last dose (Up to approximately 12 months)
Title
The Number of Participants With Adjudicated Major Bleeding
Description
The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). Major bleeding is defined as bleeding that satisfies one or more of the following criteria: fatal bleeding clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS bleeding that requires surgical intervention in an operating suite, including interventional radiology
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Title
The Number of Participants With Adjudicated CRNM Bleeding
Description
The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC). CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Title
The Number of Participants With All Adjudicated Bleeding
Description
The number of participants with all adjudicated bleeding events
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Title
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
Description
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Title
The Number of Participant Deaths in the Study
Description
The number of participant deaths in the study.
Time Frame
From first dose to 2 days after last dose (Up to approximately 12 months)
Title
Maximum Observed Concentration (Cmax)
Time Frame
From first dose up to 6 months after first dose
Title
Trough Observed Concentration (Cmin)
Time Frame
From first dose up to 6 months after first dose
Title
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Time Frame
From first dose up to 6 months after first dose
Title
Time of Maximum Observed Concentration (Tmax)
Time Frame
From first dose up to 6 months after first dose
Title
Anti-FXa Activity
Description
Anti-FXa Activity was measured to assess participant plasma apixaban levels. 125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.
Time Frame
From first dose up to 6 months after first dose
Title
Chromogenic FX Assay (Apparent FX Level)
Description
Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban. 125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.
Time Frame
From first dose up to 6 months after first dose
Title
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Description
Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot). Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.
Time Frame
from randomization up to 12 months after randomization
Title
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Description
Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses. KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.
Time Frame
from randomization up to 12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children'S Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University Of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0641
Country
United States
Facility Name
Children'S Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Childrens Healthcare Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0008
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Local Institution - 0009
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Local Institution - 0013
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Childrens Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Local Institution - 0006
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0012
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0011
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Local Institution - 0055
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Local Institution
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0030
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution - 0001
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0022
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Instituto De Cardiologia Do Rio Grande Do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Local Institution - 0020
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Instituto de Pesquisa PENSI
City
Sao Paulo
ZIP/Postal Code
01227-200
Country
Brazil
Facility Name
Universidade Federal De Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Facility Name
Local Institution - 0015
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Local Institution - 0031
City
HUS
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution - 0002
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 0004
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution - 0003
City
Muenchen
ZIP/Postal Code
80636
Country
Germany
Facility Name
Local Institution - 0047
City
Petach Tikva
ZIP/Postal Code
0
Country
Israel
Facility Name
Local Institution - 0046
City
Tel Hashomer
ZIP/Postal Code
52620
Country
Israel
Facility Name
Local Institution - 0026
City
Rome
State/Province
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Local Institution - 0028
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 0027
City
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Local Institution - 0018
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Local Institution - 0019
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution - 0016
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0044
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution - 0062
City
Ekaterinburg
ZIP/Postal Code
620134
Country
Russian Federation
Facility Name
Local Institution
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Local Institution
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Local Institution - 0057
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Local Institution - 0049
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 0048
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution - 0040
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Local Institution - 0042
City
Bristol
State/Province
Somerset
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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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