E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SYMPTOMATIC ISOLATED DISTAL DEEP VEIN THROMBOSIS |
Trombosi Venose Distali Isolate sintomatiche |
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E.1.1.1 | Medical condition in easily understood language |
SYMPTOMATIC ISOLATED DISTAL DEEP VEIN THROMBOSIS |
Trombosi Venose Distali Isolate sintomatiche |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049915 |
E.1.2 | Term | Deep venous thrombosis distal |
E.1.2 | System Organ Class | 100000004866 |
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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 |
Efficacy: to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic IDDVT of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban. Safety: to assess the incidence of treatment emergent major bleeding.
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valutare il rischio a lungo termine di recidive tromboemboliche confrontando due durate diverse della terapia anticoagulante con rivaroxaban, somministrato per 6 settimane o per 12 settimane. Sicurezza: valutare l'incidenza di eventi emorragici maggiori. L’obiettivo di sicurezza primario è rappresentato dall’incidenza degli eventi emorragici maggiori. Questi eventi vengono ritenuti attribuibili a rivaroxaban se avvengono entro 2 giorni dall’ultima assunzione del farmaco
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E.2.2 | Secondary objectives of the trial |
- to assess the incidence of cardiovascular events; - to assess the incidence of clinically relevant non-major bleeding events (CRNMB) - to assess the incidence and type of VTE recurrences during a 24 months period of follow-up - Residual clot or clot resolution at 3 and 24 months
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- Valutare l'incidenza di eventi cardiovascolari; - Per valutare l'incidenza di eventi di sanguinamento non-principali ma clinicamente rilevanti (CRUMB) - Coagulo residuo o risoluzione coagulo a 3 e 24 mesi - valutare l'incidenza e il tipo di recidive di TEV in un periodo di 24 mesi di follow-up
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of thrombosis in one or more infra-popliteal deep veins of the leg (including distal thromboses that reach the trifurcation area or the muscular ones). Diagnosis should be made by an ultrasonographic study extended to the whole deep vein system of both legs. Patients are eligible only if the diagnosis of IDDVT was obtained within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of LMWH: 6 doses; of fondaparinux: 3 doses).
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Pazienti ricoverati o ambulatoriali con diagnosi confermata di IDDVT della gamba (trombosi di una o più vene profonde incluse trombosi estese fino all’area di triforcazione e le vene muscolari), sia idiopatica che secondaria, ottenuta entro 72 ore dalla valutazione per l’inclusione nello studio; - i pazienti devono aver ricevuto un trattamento anticoagulante parenterale prima dell’arruolamento per non più di 3 giorni (6 dosi terapeutiche massimo di eparina a basso peso molecolare e 3 di fondaparinux) |
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E.4 | Principal exclusion criteria |
1. Age < 18 years 2. Any absolute contraindication to anticoagulant treatment 3. Pregnancy or breast-feeding 4. Presence of active cancer 5. Concomitant presence of proximal DVT or pulmonary embolism 6. Any concomitant indication for long-term anticoagulant treatment 7. Creatinine clearance =30 ml/min, according to Cockcroft-Gault equation 8. Cirrhosis Child-Pugh score B or C 9. Liver disease associated with coagulopathy and high risk of bleeding 10. Any other contraindication to rivaroxaban as per local SmPC 11. Failure to provide written informed consent
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1. Età < 18 anni 2. Assoluta controindicazione al trattamento anticoagulante 3. Gravidanza o allattamento 4. Presenza di cancro attivo 5. Concomitante presenza di trombosi venosa prossimale o embolia polmonare 6. Altre concomitanti indicazioni al trattamento anticoagulante a lungo termine 7. Clearance della Creatinina =30 ml/min, calcolata con l’equazione di Cockcroft-Gault 8. Cirrosi epatica Child-Pugh score B or C 9. Epatopatia associata a coagulopatia e alto rischio di sanguinamento 10. Controindicazioni al rivaroxaban secondo scheda tecnica 11. Mancato ottenimento del consenso informato scritto |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome of the study is the incidence of recurrent VTE within 24 months from the inclusion. The primary safety outcome is the incidence of treatment emergent major bleeding. Bleeding events will be considered associated with rivaroxaban treatment if they occur within 2 days from the last intake of the drug.
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L’ endpoint primario di efficacia dello studio è rappresentato dall’incidenza di eventi tromboembolici venosi osservati in un periodo di 24 mesi dall’inclusione nello studio. L’endopint di sicurezza primario è rappresentato dall’incidenza degli eventi emorragici maggiori. Questi eventi vengono ritenuti attribuibili a rivaroxaban se avvengono entro 2 giorni dall’ultima assunzione del farmaco.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 months for efficacy endpoint |
24 mesi per l'endopint di efficacia |
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E.5.2 | Secondary end point(s) |
a) Secondary efficacy outcomes: incidence of cardiovascular events b) Secondary safety outcomes: incidence of clinically relevant non-major bleeding events (CRNMB) c) Residual clot or clot resolution at 3 and 24 months
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Secondari: - 'incidenza di eventi cardiovascolari; - 'incidenza di eventi di sanguinamento non-principali ma clinicamente rilevanti (CRUMB) - Coagulo residuo o risoluzione coagulo a 3 e 24 mesi
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 and 24 months |
3 e 24 mesi |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
prima fase in aperto per 6 settimane e poi 6 settimane di trattamento randomizzato in doppio cieco |
open-label for the first 6 weeks, following by a 6 weeks randomised double blind period |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 27 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |