CCPC
Ancona, The Marches, 60123, Italy
Location status: Recruiting
NCT Number: NCT06371170
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.
Interested in participating?
Request Info1 month–16 year
All sexes
Observational
Ancona, The Marches, 60123, Italy
Location status: Recruiting
The Investigators will enroll all the consecutive pediatric patients (< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months.
The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral anticoagulation
Other names: Xarelto
Time frame: 3 months
Rate of intracardiac thrombus resolution at CMR/CCT imaging
Time frame: 3 months
Rate of major bleeding utilizing the BASIC bleeding score
Contact information is provided by the study sponsor or research team.
Francesco Bianco, M.D., Ph.D.
CONTACT
Valentina Bucciarelli, M.D., Ph.D.
CONTACT
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Other
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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