Using rivaroxaban to treat heart clots in children
Official title: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
Run by Azienda Ospedaliero, Universitaria Ospedali Riuniti · NCT06371170 · Data updated 2026-11-12
This study is testing if the blood thinner rivaroxaban can help children under 16 get rid of heart clots more effectively than current treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 16 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti Academic / other |
| Locations | 1 site (Ancona, The Marches) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | January 1, 2025 |
| Study ends | January 1, 2027 |
| Registry record updated | April 19, 2024 |
| Trial ID | NCT06371170 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pediatric patients under 16 years old diagnosed with intracardiac thrombosis confirmed by imaging.
✕Probably not a fit
Patients with major bleeding events or abnormal coagulation tests prior to enrollment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of rivaroxaban in resolving intracardiac thrombi in pediatric patients under 16 years old. Participants who are already receiving rivaroxaban as part of their medical care will be monitored over a 3-month period with monthly visits to assess treatment progress and bleeding risks. The study will involve initial treatment with enoxaparin for 7 days, followed by rivaroxaban, with imaging studies conducted before and after treatment to confirm thrombus resolution. The primary goal is to determine if rivaroxaban can effectively resolve the thrombosis within the treatment timeframe.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and effective option for resolving heart clots in pediatric patients.
How similar studies have gone: While rivaroxaban has been studied in adults, this specific application in pediatric patients is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ccpc
Ancona, The Marches, Italy Recruiting
Study contacts
- Principal investigator: Francesco Bianco, M.D., Ph.D. — AOU - Ospedali Riuniti Ancona
- Study coordinator: Francesco Bianco, M.D., Ph.D.
- Email: francesco.bianco@ospedaliriuniti.marche.it
- Phone: +39 071 5965283
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.