Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02981472
Registration number
NCT02981472
Ethics application status
Date submitted
18/11/2016
Date registered
5/12/2016
Date last updated
3/10/2022
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2016-001247-39
Query!
Secondary ID [2]
0
0
CV185-362
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Thrombosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Vitamin K Antagonist (VKA)
Treatment: Drugs - Low Molecular Weight Heparin (LMWH)
Experimental: Apixaban -
Active Comparator: LMWH/VKA -
Treatment: Drugs: Apixaban
Specified dose on specified days
Treatment: Drugs: Vitamin K Antagonist (VKA)
Specified dose on specified days
Treatment: Drugs: Low Molecular Weight Heparin (LMWH)
Specified dose on specified days
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [1]
0
0
The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
Query!
Assessment method [1]
0
0
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)
Query!
Timepoint [1]
0
0
From randomization to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [2]
0
0
The Number of Participants With Adjudicated Major Bleeding
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [3]
0
0
The Number of Participants With Adjudicated CRNM Bleeding
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [4]
0
0
The Number of Participants With All Adjudicated Bleeding
Query!
Assessment method [4]
0
0
The number of participants with all adjudicated bleeding events
Query!
Timepoint [4]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [5]
0
0
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
Query!
Assessment method [5]
0
0
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
Query!
Timepoint [5]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [6]
0
0
The Number of Participant Deaths in the Study
Query!
Assessment method [6]
0
0
The number of participant deaths in the study.
Query!
Timepoint [6]
0
0
From first dose to 2 days after last dose (Up to approximately 12 months)
Query!
Secondary outcome [7]
0
0
Maximum Observed Concentration (Cmax)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [8]
0
0
Trough Observed Concentration (Cmin)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [9]
0
0
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [10]
0
0
Time of Maximum Observed Concentration (Tmax)
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [11]
0
0
Anti-FXa Activity
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [12]
0
0
Chromogenic FX Assay (Apparent FX Level)
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
From first dose up to 6 months after first dose
Query!
Secondary outcome [13]
0
0
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
from randomization up to 12 months after randomization
Query!
Secondary outcome [14]
0
0
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
from randomization up to 12 months after randomization
Query!
Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
- 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
Query!
Minimum age
28
Days
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/01/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/10/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
192
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - 0030 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
3052 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Utah
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Vienna
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Parana
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Rio Grande Do Sul
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Sao Paulo
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Finland
Query!
State/province [21]
0
0
HUS
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Freiburg
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Hamburg
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Muenchen
Query!
Country [25]
0
0
Israel
Query!
State/province [25]
0
0
Petach Tikva
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
Tel Hashomer
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Roma
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Bologna
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Milano
Query!
Country [30]
0
0
Mexico
Query!
State/province [30]
0
0
Distrito Federal
Query!
Country [31]
0
0
Mexico
Query!
State/province [31]
0
0
Guanajuato
Query!
Country [32]
0
0
Russian Federation
Query!
State/province [32]
0
0
Ekaterinburg
Query!
Country [33]
0
0
Russian Federation
Query!
State/province [33]
0
0
Kazan
Query!
Country [34]
0
0
Russian Federation
Query!
State/province [34]
0
0
Kemerovo
Query!
Country [35]
0
0
Russian Federation
Query!
State/province [35]
0
0
Novosibirsk
Query!
Country [36]
0
0
Spain
Query!
State/province [36]
0
0
Barcelona
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Madrid
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Leicestershire
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Somerset
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Pediatric Heart Network
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
Pfizer
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or
acquired heart disease who have a need for anticoagulation.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02981472
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02981472
Download to PDF