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Clinical Trials in Italy / NCT06371170
Recruiting Observational

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

NCT06371170 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Phase
Observational
Started
2023-01-01
Last updated
2024-04-19

Condition(s) studied

Intracardiac Thrombus

Investigational drug(s) / intervention(s)

Rivaroxaban →

Rivaroxaban: Oral anticoagulation

Study summary

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

Sex
ALL
Min age
1 Month
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: * Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation * Given informed consent from the parents or tutors Exclusion Criteria: * \< 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CCPC Ancona The Marches Recruiting

On this site

📄 Xarelto (rivaroxaban) drug profile →

More Azienda Ospedaliero, Universitaria Ospedali Riuniti trials in Italy

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Efficacy of a Myocardial Panel in the Management and Treatment of Pediatric Myocarditis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06371170 on ClinicalTrials.gov ↗ ← All trials in Italy