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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2016-001247-39
Secondary ID [2] 0 0
CV185-362
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
Timepoint [1] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [1] 0 0
The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
Timepoint [1] 0 0
From randomization to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [2] 0 0
The Number of Participants With Adjudicated Major Bleeding
Timepoint [2] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [3] 0 0
The Number of Participants With Adjudicated CRNM Bleeding
Timepoint [3] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [4] 0 0
The Number of Participants With All Adjudicated Bleeding
Timepoint [4] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [5] 0 0
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
Timepoint [5] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [6] 0 0
The Number of Participant Deaths in the Study
Timepoint [6] 0 0
From first dose to 2 days after last dose (Up to approximately 12 months)
Secondary outcome [7] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [7] 0 0
From first dose up to 6 months after first dose
Secondary outcome [8] 0 0
Trough Observed Concentration (Cmin)
Timepoint [8] 0 0
From first dose up to 6 months after first dose
Secondary outcome [9] 0 0
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
Timepoint [9] 0 0
From first dose up to 6 months after first dose
Secondary outcome [10] 0 0
Time of Maximum Observed Concentration (Tmax)
Timepoint [10] 0 0
From first dose up to 6 months after first dose
Secondary outcome [11] 0 0
Anti-FXa Activity
Timepoint [11] 0 0
From first dose up to 6 months after first dose
Secondary outcome [12] 0 0
Chromogenic FX Assay (Apparent FX Level)
Timepoint [12] 0 0
From first dose up to 6 months after first dose
Secondary outcome [13] 0 0
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
Timepoint [13] 0 0
from randomization up to 12 months after randomization
Secondary outcome [14] 0 0
Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
Timepoint [14] 0 0
from randomization up to 12 months after randomization

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
Minimum age
28 Days
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/10/2021
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 0030 - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Austria
State/province [16] 0 0
Vienna
Country [17] 0 0
Brazil
State/province [17] 0 0
Parana
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Finland
State/province [21] 0 0
HUS
Country [22] 0 0
Germany
State/province [22] 0 0
Freiburg
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Muenchen
Country [25] 0 0
Israel
State/province [25] 0 0
Petach Tikva
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Hashomer
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Mexico
State/province [30] 0 0
Distrito Federal
Country [31] 0 0
Mexico
State/province [31] 0 0
Guanajuato
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Ekaterinburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Kazan
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Kemerovo
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Novosibirsk
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Leicestershire
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Somerset
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pediatric Heart Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Pfizer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02981472