Study of the Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulatio

Phase 1

• Conditions: Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention; MedDRA version: 20.0Level: PTClassification code 10019273Term: Heart disease congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: PTClassification code 10007636Term: CardiomyopathySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10019276Term: Heart disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 21.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001247-39-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-18
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

•Males and females, 37 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]
•Participants 28 days to <3 months must be able to tolerate oral/NGT/GT feed for at least 5 days prior to randomization.
Are the trial subjects under 18? yes
Number of subjects for this age range: 215
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 Antiphospholipid Syndrom (APS).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified