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NCT Number: NCT06371170

Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

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.

Recruiting

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Key information

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

Oral anticoagulation

Other names: Xarelto

Primary outcomes

  1. Thrombus resolution

    Time frame: 3 months

    Rate of intracardiac thrombus resolution at CMR/CCT imaging

Secondary outcomes

  1. Bleeding

    Time frame: 3 months

    Rate of major bleeding utilizing the BASIC bleeding score

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Bianco, M.D., Ph.D.

CONTACT

[email protected]

+39 071 5965283

Valentina Bucciarelli, M.D., Ph.D.

CONTACT

[email protected]

+39 071 5965283

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Apr 17, 2024
Registry last updated
Apr 19, 2024

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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