RecruitingNCT06371170

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites


Sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Enrollment

20 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 MonthMax Age: 16 Years

Inclusion Criteria2

  • Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
  • Given informed consent from the parents or tutors

Exclusion Criteria4

  • < 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRivaroxaban

Oral anticoagulation


Locations(1)

CCPC

Ancona, The Marches, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06371170