Portal, mesenteric, and splenic vein thrombosis MedDRA version: 18.0 Level: LLT Classification code 10043642 Term: Thrombosis venous deep System Organ Class: 100000004866
Conditions
Interventions
Trade Name: XARELTO - 15 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE BLISTER (PP/ALU) 100 (10X10X1) COMPRESSE (DOSE UNITARIA) (CONFEZIONE MULTIPLA)
Product Name: RIVAROXABAN
Pharmaceutical Form: Tab
Sponsors
A.O. OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of rivaroxaban in the treatment of patients with SVT;Secondary Objective: Efficacy in terms of recurrence and mortality;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;Timepoint(s) of evaluation of this end point: 3 months+2 days after the end of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: 3 months+ 2 days after the end of the study treatment | — |
Countries
Germany, Italy, Netherlands
Contacts
Public ContactSegreteria Tecnico-Scientifica CE
AO Ospedale di Circolo e Fondazione Macchi
Outcome results
None listed