EUCTR2016-001247-39-FIActive, not recruitingPhase 1
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 - Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children
Bristol-Myers Squibb International Corporation0 sites150 target enrollmentStarted: February 23, 2017Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Males and females, 34 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]
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •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
Investigators
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