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Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06371170
Enrollment
20
Registered
2024-04-17
Start date
2023-01-01
Completion date
2027-01-01
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracardiac Thrombus

Brief 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.

Detailed description

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.

Interventions

DRUGRivaroxaban

Oral anticoagulation

Sponsors

Azienda Ospedaliero, Universitaria Ospedali Riuniti
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 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

Design outcomes

Primary

MeasureTime frameDescription
Thrombus resolution3 monthsRate of intracardiac thrombus resolution at CMR/CCT imaging

Secondary

MeasureTime frameDescription
Bleeding3 monthsRate of major bleeding utilizing the BASIC bleeding score

Countries

Italy

Contacts

Primary ContactFrancesco Bianco, M.D., Ph.D.
francesco.bianco@ospedaliriuniti.marche.it+39 071 5965283
Backup ContactValentina Bucciarelli, M.D., Ph.D.
valentina.bucciarelli@ospedaliriuniti.it+39 071 5965283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026