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NCT Number: NCT06193863

An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure.

Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death.

The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding.

A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients.

To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.

The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated.

The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years.

In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prevention of Venous Thromboembolism Cardiovascular Abnormalities Cardiovascular Diseases Children Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fontan Procedure Heart Defects, Congenital Heart Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients under the age of 18 years
  • Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice
  • Informed consent form obtained from a legal representative

Exclusion criteria

  • Participation in an investigational program with interventions outside of routine clinical practice
  • Contraindications according to the local marketing authorization
  • Previous treatment with rivaroxaban

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

At the discretion of the treating physician, based on the recommendations written in the local product information.

Primary outcomes

  1. Occurrence of major bleeding or clinically relevant non-major bleeding

    Time frame: Up to 2 years

Secondary outcomes

  1. Occurrence of any bleeding

    Time frame: Up to 2 years

  2. Occurrence of all adverse events (AEs)

    Time frame: Up to 2 years

  3. Occurrence of thrombotic events

    Time frame: Up to 2 years

  4. Descriptive summary of patient demographics/characteristics

    Time frame: Up to 2 years

  5. Dosing patterns of rivaroxaban

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Special Drug Use Investigation of Rivaroxaban in Pediatric Patients With Congenital Heart Disease (CHD) Who Had Undergone the Fontan Procedure

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jul 10, 2026

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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