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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT02981472
• Date of registration: 18/11/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• 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
• Date of first enrolment: January 19, 2017
• Target sample size: 192
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02981472
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, Finland, France, Germany, Israel, Italy, Mexico, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 28 Days
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Thrombosis

Intervention(s)

Drug: Apixaban

Drug: Low Molecular Weight Heparin (LMWH)

Drug: Vitamin K Antagonist (VKA)

Primary Outcome(s)

Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events [Time Frame: From first dose to 2 days after last dose (Up to approximately 12 months)]

Secondary Outcome(s)

Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score [Time Frame: from randomization up to 12 months after randomization]

Chromogenic FX Assay (Apparent FX Level) [Time Frame: From first dose up to 6 months after first dose]

The Number of Participant Deaths in the Study [Time Frame: From first dose to 2 days after last dose (Up to approximately 12 months)]

The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death [Time Frame: From randomization to 2 days after last dose (Up to approximately 12 months)]

The Number of Participants With All Adjudicated Bleeding [Time Frame: From first dose to 2 days after last dose (Up to approximately 12 months)]

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)]

The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL) [Time Frame: from randomization up to 12 months after randomization]

Anti-FXa Activity [Time Frame: From first dose up to 6 months after first dose]

Maximum Observed Concentration (Cmax) [Time Frame: From first dose up to 6 months after first dose]

The Number of Participants With Adjudicated Major Bleeding [Time Frame: From first dose to 2 days after last dose (Up to approximately 12 months)]

The Number of Participants With Adjudicated CRNM Bleeding [Time Frame: From first dose to 2 days after last dose (Up to approximately 12 months)]

Time of Maximum Observed Concentration (Tmax) [Time Frame: From first dose up to 6 months after first dose]

Trough Observed Concentration (Cmin) [Time Frame: From first dose up to 6 months after first dose]

Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU)) [Time Frame: From first dose up to 6 months after first dose]

Secondary ID(s)

2016-001247-39

CV185-362

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pediatric Heart Network

Pfizer

Results

• Results available: Yes
• Date Posted: 18/05/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02981472