E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of venous thromboembolism after laparoscopic surgery for colorectal cancer |
Prevenzione del tromboembolismo venoso dopo chirurgia laparoscopica per neoplasia del colon-retto |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of venous thrombosis and pulmonary embolism after laparoscopic surgery for colorectal cancer |
Prevenzione della trombosi venosa e dell'embolia |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067650 |
E.1.2 | Term | Pulmonary embolism prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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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 | 10012108 |
E.1.2 | Term | Deep venous thrombosis prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
To assess the efficacy and safety of postdischarge extended (3 weeks) antithrombotic prophylaxis with rivaroxaban compared to placebo after planned laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with LMWH during the hospital stay for 7±2 days |
Valutare efficacia e sicurezza della profilassi antitrombotica estesa (fino a 28±2 giorni dall’intervento) con rivaroxaban rispetto al placebo in pazienti sottoposti a chirurgia laparoscopica per neoplasia del colon retto, tutti trattati con profilassi eparinica per 7±2 giorni dopo l’intervento chirurgico |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy and safety at 90 days of post-discharge extended (3 weeks) antithrombotic prophylaxis with rivaroxaban compared to placebo after planned laparoscopic surgery for colorectal cancer in patients who had received antithrombotic prophylaxis with LMWH during the hospital stay for 7±2 days |
Valutare efficacia e sicurezza a 90 giorni della profilassi antitrombotica estesa (fino a 28±2 giorni dall’intervento) con rivaroxaban rispetto al placebo in pazienti sottoposti a chirurgia laparoscopica per neoplasia del colon retto, tutti trattati con profilassi eparinica per 7±2 giorni dopo l’intervento chirurgico |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Objective diagnosis of Colorectal Cancer - Elective laparoscopic surgery for colorectal cancer - Whatever the stage of cancer - Antithrombotic prophylaxis with LMWH administered for 7±2 days after surgery |
- Diagnosi oggettiva di cancro colo-rettale - Chirurgia laparoscopica elettiva per neoplasia colo-rettale - Qualunque sia lo stadio del tumore - Profilassi antitrombotica con eparina a basso peso molecolare somministrata per 7 ± 2 giorni dopo l'intervento |
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E.4 | Principal exclusion criteria |
- age < 18 years - surgery for non-cancer disease - duration of surgery < 45 min - Conversion to open surgery - other indication for anticoagulant therapy - known cerebral metastases - kidney or liver failure - known hemorrhagic diathesis or high risk for bleeding - history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia - pregnancy or lactation - refusal of informed consent |
- Età <18 anni - Intervento chirurgico per patologia non oncologica - Durata dell'intervento <45 min - Conversione alla chirurgia laparotomica - Altra indicazione per la terapia anticoagulante - Metastasi cerebrali note - Insufficienza renale o epatica - Diatesi emorragica o ad alto rischio di sanguinamento - Storia di emorragia cerebrale o neurochirurgia entro 6 mesi, storia di trombocitopenia indotta da eparina - Gravidanza o allattamento - Rifiuto del consenso informato |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study outcome is a composite of symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death at 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo. Pulmonary embolism will be diagnosed in the presence of: - intraluminal filling defect at computed tomography angiography or pulmonary angiography - high probability perfusion defect at perfusion lung scan with mismatch area compared to chest X Ray. Deep vein thrombosis will be diagnosed in the presence of: - an uncompressible vein segment in the deep vein of the lower limbs as assessed by complete compression ultrasonography examination |
L’outcome primario di efficacia è un composito di tromboembolismo venoso sintomatico oggettivamente confermato, trombosi venosa profonda diagnosticata all’ecoDoppler e/o morte correlata a tromboembolismo venoso a 30 giorni dall’intervento di chirurgia laparoscopica per neoplasia del colon nei pazienti randomizzati a rivaroxaban o placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 days from surgery |
a 28 giorni dall'intervento |
|
E.5.2 | Secondary end point(s) |
1) symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 28±2 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo;; 2) symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT, major bleeding or death at 90 days from planned laparoscopic surgery for colorectal cancer in patients randomized to rivaroxaban or placebo |
1) tromboembolismo venoso sintomatico oggettivamente confermato, trombosi venosa profonda diagnosticata all’ecoDoppler, sanguinamento maggiore o morte a 28 ± 2 giorni dalla chirurgia laparoscopica per neoplasia del colon-retto nei pazienti randomizzati a rivaroxaban o placebo;; 2) tromboembolismo venoso sintomatico oggettivamente confermato, trombosi venosa profonda diagnosticata all’ecoDoppler, sanguinamento maggiore o morte a 90 giorni dalla chirurgia laparoscopica per neoplasia del colon-retto nei pazienti randomizzati a rivaroxaban o placebo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 days from surgery; 90 days from surgery |
a 28 giorni dall'intervento; 90 giorni dall'intervento |
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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 | Yes |
E.6.3 | Therapy | No |
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 | No |
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 | 19 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |