Using rivaroxaban to treat heart clots in children
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 1 Month to 16 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Ospedali Riuniti Academic / other |
| Locations | 1 site (Ancona, The Marches) |
| Trial ID | NCT06371170 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 16 years old diagnosed with intracardiac thrombosis confirmed by imaging.
Not a fit: Patients with major bleeding events or abnormal coagulation tests prior to enrollment may not benefit from this study.
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 performed: While rivaroxaban has been studied in adults, this specific application in pediatric patients is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Ancona, The Marches
- 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 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.