About this trial
The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?
Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
Given informed consent from the parents or tutors
Disqualifiers
< 38 weeks of gestational birth
< 10 days of oral feeding and body weight
< 2.6 Kg
Any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days prior to the enrollment for the whole population
Trial population
Pediatric patients (neonates and pediatrics) diagnosed with intracardiac thrombosis at any possible cardiac site (right/left ventricle, right/left atria, or auricola).
Trial design
Cohort
Prospective
Treatments tested in this trial
Rivaroxaban
DrugOral anticoagulation
Treatment groups
Trial outcomes
Primary outcomes
Thrombus resolution
Rate of intracardiac thrombus resolution at CMR/CCT imaging
Secondary outcomes
Bleeding
Rate of major bleeding utilizing the BASIC bleeding score
Sponsors and contacts
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