Observing the safety and effectiveness of rivaroxaban in children after heart surgery
Special Drug Use Investigation of Rivaroxaban in Pediatric Patients With Congenital Heart Disease (CHD) Who Had Undergone the Fontan Procedure
This study is testing how well rivaroxaban works and how safe it is for children with congenital heart disease who have had heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06193863 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze data from children with congenital heart disease who have undergone the Fontan procedure and are prescribed rivaroxaban. The study will focus on understanding how well rivaroxaban works in preventing blood clots and assessing its safety profile in this specific pediatric population. By monitoring these patients, researchers hope to gather insights into the risks and benefits of using rivaroxaban compared to other treatments like aspirin. The findings could help inform future treatment guidelines for children with congenital heart disease.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old diagnosed with congenital heart disease who have undergone the Fontan procedure and are being treated with rivaroxaban.
Not a fit: Patients who have contraindications to rivaroxaban or have previously been treated with it may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safe use of rivaroxaban in preventing blood clots in children after heart surgery.
How similar studies have performed: Previous studies have suggested that rivaroxaban may have a comparable safety profile to aspirin in children with congenital heart disease, indicating potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Multiple Locations
- Many Locations — Multiple Locations, Japan (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.