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
NCT ID: NCT06193863
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-06-18
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rivaroxaban
Pediatric patients with CHD who had undergone the Fontan procedure were prescribed with Xarelto before enrollment.
Rivaroxaban (Xarelto, BAY59-7939)
At the discretion of the treating physician, based on the recommendations written in the local product information.
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
At the discretion of the treating physician, based on the recommendations written in the local product information.
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindications according to the local marketing authorization
* Previous treatment with rivaroxaban
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , Japan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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22468
Identifier Type: -
Identifier Source: org_study_id