E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Portal, mesenteric, and splenic vein thrombosis |
Trombosi venose portali, mesenteriche e spleniche |
|
E.1.1.1 | Medical condition in easily understood language |
Vein thrombosis |
Trombosi venose |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043642 |
E.1.2 | Term | Thrombosis venous deep |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety of rivaroxaban in the treatment of patients with SVT |
Valutare la sicurezza di rivaroxaban nel trattamento delle trombosi venose portali, mesenteriche e spleniche definite come emorragie maggiori |
|
E.2.2 | Secondary objectives of the trial |
Efficacy in terms of recurrence and mortality |
Efficacia in termini di recidive e mortalità |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Consecutive patients aged 18 years or older with a first episode of symptomatic, objectively diagnosed PVT, MVT, or spVT will be eligible. The following diagnostic procedures will be accepted: computerized tomography, magnetic resonance imaging, and Doppler ultrasound. All eligible patients will need to provide signed informed consent. |
pazienti consecutivi di età superiore a 18 anni con un primo episodio sintomatico di trombosi venosa splancnica (vena porta, vene mesenteriche, vena splenica) diagnosticato mediante appropriate indagini radiologiche. Tutti i pazienti dovranno avere firmato il modulo di consenso informato dopo adeguata istruzione sullo studio. |
|
E.4 | Principal exclusion criteria |
Known liver cirrhosis (biopsy proven or with clinical, laboratory, or imaging evidence of chronic liver disease, within a context of chronic alcoholism, viral hepatitis, autoimmunity, Wilson’s disease, iron overload) or an alanine aminotransferase level that is three times the upper limit of the normal range or higher; Budd-Chiari syndrome; previous or ongoing variceal bleeding; presence of portal vein cavernoma at the time of diagnosis; anticipated abdominal surgical procedure; known bleeding diathesis; platelet count <100.000 mm3; creatinine clearance <30 mL/min (Cockroft-Gault formula); life expectancy of less than 3 months; expected inability to take oral medications; concomitant treatment with azole antimycotics and human immunodeficiency virus protease inhibitors; pregnancy or lactation; treatment with therapeutic doses of LMWH or UFH for more than 7 days; ongoing treatment with VKA. |
Presenza di cirrosi epatica o epatite acuta; sindrome di Budd-Chiari; sanguinamento da varici pregresso o attivo; presenza di cavernoma portale alla diagnosi; indicazione a procedura chirurgica addominale; nota diatesi emorragica; conta piastrinica <100.000 mm3; clearance della creatinina <30 mL/min; aspettativa di vita <3 mesi; impossibilità ad assumere terapia per via orale; terapia concomitante con antimicotici azolici o terapia antiretrovirale per HIV; gravidanza o allattamento; trattamento con dosi terapeutiche con eparina a basso peso molecolare o eparina non frazionata per più di 7 giorni; terapia in corso con antagonisti della vitamina K. for more than 7 days; ongoing treatment with VKA. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of major bleeding events during the 3 months of active treatment and up to 2 days after the end of study treatment |
Incidenza di emorragie maggiori (secondo i criteri ISTH) durante i 3 mesi di trattamento attivo e fino a 2 giorni dopo la sospensione del farmaco. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 months+2 days after the end of study treatment |
3 mesi + 2 giorni dopo la sospensione del farmaco. |
|
E.5.2 | Secondary end point(s) |
Mortality, clinically relevant non-major bleeding occurred during 3 months of active treatment and up to 2 days after the end of the study treatment, detection of alanine aminotransferase levels of three times te upper limit of the normal range or higher with or without bilirubin levels of two times the upper limit of the normal range or higher during follow-up, recurrent SVT, symtomatic VTE in other sites |
Mortalità totale e secondaria alla trombosi venosa splancnica,emorragie non definibili maggiori ma clinicamente rilevanti, incremento patologico delle transaminasi e/o della bilirubina, ricanalizzazione venosa, recidiva di trombosi venosa splancnica, trombosi venose in altri distretti |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 months+ 2 days after the end of the study treatment |
3 mesi + 2 giorni dalla fine dello studio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 90 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 30 |
E.8.9.2 | In all countries concerned by the trial days | 30 |