Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

NCT06371170 | Recruiting

• 1 other identifier: CCPC- 001/22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intracardiac Thrombus

Outcome Measures

Primary Outcomes (1)

• Thrombus resolution

  Rate of intracardiac thrombus resolution at CMR/CCT imaging

  3 months

Secondary Outcomes (1)

• Bleeding

  3 months

Interventions

Rivaroxaban DRUG

Oral anticoagulation

Also known as: Xarelto

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients (neonates and pediatrics) diagnosed with intracardiac thrombosis at any possible cardiac site (right/left ventricle, right/left atria, or auricola).

You may qualify if:

• Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
• Given informed consent from the parents or tutors

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (1)

CCPC

Ancona, The Marches, 60123, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 8225659 BACKGROUND

• Yang 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.

  PMID: 20305543 BACKGROUND

• Nellis 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.

  PMID: 31567407 BACKGROUND

• Male 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.

  PMID: 31699660 BACKGROUND

• Agarwal 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.

  PMID: 38193068 BACKGROUND

• Cappelletti 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.

  PMID: 40628107 DERIVED

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Francesco Bianco, M.D., Ph.D.

  AOU - Ospedali Riuniti Ancona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Bianco, M.D., Ph.D.

CONTACT

+39 071 5965283; francesco.bianco@ospedaliriuniti.marche.it

Valentina Bucciarelli, M.D., Ph.D.

CONTACT

+39 071 5965283; valentina.bucciarelli@ospedaliriuniti.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

IT (1)