Intracardiac ThrombusNCT06371170
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population
An observational study of Intracardiac Thrombus, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.
Trial summary
The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (< 16 years old) diagnosed with intracardiac thrombosis. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Intracardiac Thrombus
- What is being tested?
- Rivaroxaban
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Jan 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (neonates and pediatrics) diagnosed with intracardiac thrombosis at any possible cardiac site (right/left ventricle, right/left atria, or auricola).
Who may be able to join
- Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
- Given informed consent from the parents or tutors
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CCPC
Ancona, The Marches, 60123
Francesco Bianco, M.D., +39 071 596 5316, francesco.bianco@ospedaliriuniti.marche.it
About this study
Official title: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?
Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.
Read the detailed description
The Investigators will enroll all the consecutive pediatric patients (< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months.
The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.
- Conditions
- Intracardiac Thrombus
- Being tested
- Rivaroxaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Xarelto
Oral anticoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus resolution
Rate of intracardiac thrombus resolution at CMR/CCT imaging
Measured: 3 months
Secondary outcomes (1)
Bleeding
Rate of major bleeding utilizing the BASIC bleeding score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracardiac ThrombusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Bianco, Azienda Ospedaliero, Universitaria Ospedali Riuniti
- Investigators
- Francesco Bianco, M.D., Ph.D., Principal investigator, AOU - Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371170
- Sponsor's protocol ID
- CCPC- 001/22
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request, the data will be shared depending on the requests
Publications
Ozkutlu S, Ozbarlas N, Ozme S, Saraclar M, Gogus S, Demircin M. Intracardiac thrombosis diagnosed by echocardiography in childhood: predisposing and etiological factors. Int J Cardiol. 1993 Jul 15;40(3):251-6. doi: 10.1016/0167-5273(93)90008-5.
PubMed 8225659Yang JY, Williams S, Brandao LR, Chan AK. Neonatal and childhood right atrial thrombosis: recognition and a risk-stratified treatment approach. Blood Coagul Fibrinolysis. 2010 Jun;21(4):301-7. doi: 10.1097/MBC.0b013e3283333c7c.
PubMed 20305543Nellis ME, Tucci M, Lacroix J, Spinella PC, Haque KD, Stock A, Steiner ME, Faustino EVS, Zantek ND, Davis PJ, Stanworth SJ, Cholette JM, Parker RI, Demaret P, Kneyber MCJ, Russell RT, Stricker PA, Vogel AM, Willems A, Josephson CD, Luban NLC, Loftis LL, Leteurtre S, Stocker CF, Goobie SM, Karam O; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; and the Pediatric Critical Care Blood Research Network (BloodNet). Bleeding Assessment Scale in Critically Ill Children (BASIC): Physician-Driven Diagnostic Criteria for Bleeding Severity. Crit Care Med. 2019 Dec;47(12):1766-1772. doi: 10.1097/CCM.0000000000004025.
PubMed 31567407Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
PubMed 31699660Agarwal S, Abdelghani E, Stanek JR, Sankar A, Cua CL, Kerlin BA, Rodriguez V. Intracardiac thrombi in pediatrics: anticoagulation approach and treatment outcomes. Res Pract Thromb Haemost. 2023 Nov 24;7(8):102266. doi: 10.1016/j.rpth.2023.102266. eCollection 2023 Nov.
PubMed 38193068Cappelletti D, Bianco F, Bucciarelli V, Raffaelli E, Bordignon L, Di Cesare G, Bucciarelli B, Bacchiocchi A, Manini C, Merlino E, Filippelli S, Lionetti ME. Comparison of rivaroxaban with warfarin for intracardiac thrombosis in the pediatric population at different cardiac sites: Early experience of anticoagulation approach and treatment outcomes. Thromb Res. 2025 Sep;253:109397. doi: 10.1016/j.thromres.2025.109397. Epub 2025 Jul 5.
PubMed 40628107
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population at Different Cardiac Sites
- ClinicalTrials.gov ID
- NCT06371170
- Acronym / sponsor ID
- CCPC- 001/22
- Conditions
- Intracardiac Thrombus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria Ospedali RiunitiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?
Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.
Detailed description
The Investigators will enroll all the consecutive pediatric patients (< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months.
The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (neonates and pediatrics) diagnosed with intracardiac thrombosis at any possible cardiac site (right/left ventricle, right/left atria, or auricola).
Key inclusion criteria (2 listed)
- Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
- Given informed consent from the parents or tutors
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: XareltoOral anticoagulation | Drug | – |
Primary outcome
Thrombus resolution
Time frame: 3 months
Rate of intracardiac thrombus resolution at CMR/CCT imaging
1 secondary outcome
Bleeding
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 8225659Ozkutlu S, Ozbarlas N, Ozme S, Saraclar M, Gogus S, Demircin M. Intracardiac thrombosis diagnosed by echocardiography in childhood: predisposing and etiological factors. Int J Cardiol. 1993 Jul 15;40(3):251-6. doi: 10.1016/0167-5273(93)90008-5.
- Background: PubMed 20305543Yang JY, Williams S, Brandao LR, Chan AK. Neonatal and childhood right atrial thrombosis: recognition and a risk-stratified treatment approach. Blood Coagul Fibrinolysis. 2010 Jun;21(4):301-7. doi: 10.1097/MBC.0b013e3283333c7c.
- Background: PubMed 31567407Nellis ME, Tucci M, Lacroix J, Spinella PC, Haque KD, Stock A, Steiner ME, Faustino EVS, Zantek ND, Davis PJ, Stanworth SJ, Cholette JM, Parker RI, Demaret P, Kneyber MCJ, Russell RT, Stricker PA, Vogel AM, Willems A, Josephson CD, Luban NLC, Loftis LL, Leteurtre S, Stocker CF, Goobie SM, Karam O; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; and the Pediatric Critical Care Blood Research Network (BloodNet). Bleeding Assessment Scale in Critically Ill Children (BASIC): Physician-Driven Diagnostic Criteria for Bleeding Severity. Crit Care Med. 2019 Dec;47(12):1766-1772. doi: 10.1097/CCM.0000000000004025.
- Background: PubMed 31699660Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
- Background: PubMed 38193068Agarwal S, Abdelghani E, Stanek JR, Sankar A, Cua CL, Kerlin BA, Rodriguez V. Intracardiac thrombi in pediatrics: anticoagulation approach and treatment outcomes. Res Pract Thromb Haemost. 2023 Nov 24;7(8):102266. doi: 10.1016/j.rpth.2023.102266. eCollection 2023 Nov.
- Derived from this study: PubMed 40628107Cappelletti D, Bianco F, Bucciarelli V, Raffaelli E, Bordignon L, Di Cesare G, Bucciarelli B, Bacchiocchi A, Manini C, Merlino E, Filippelli S, Lionetti ME. Comparison of rivaroxaban with warfarin for intracardiac thrombosis in the pediatric population at different cardiac sites: Early experience of anticoagulation approach and treatment outcomes. Thromb Res. 2025 Sep;253:109397. doi: 10.1016/j.thromres.2025.109397. Epub 2025 Jul 5.
- Individual participant dataSharing planned: Undecided. Upon request, the data will be shared depending on the requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesco Bianco, M.D., Ph.D. principal investigator
AOU - Ospedali Riuniti Ancona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracardiac Thrombus, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Bianco, M.D., Ph.D. (+39 071 5965283, francesco.bianco@ospedaliriuniti.marche.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus resolution (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371170, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.