E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill patients. |
Prevención del tromboembolismo venoso (TEV) sintomático y la mortalidad por TEV tras el alta hospitalaria en pacientes con procesos médicos de alto riesgo |
|
E.1.1.1 | Medical condition in easily understood language |
Prevent the occurrence of a blood clot inside a blood vessel that blocks the flow of blood through the circulatory system in patients who have been discharged from the hospital |
Prevención de la aparición de un coágulo de sangre dentro de un vaso sanguíneo que bloquea el flujo de sangre a través del sistema circulatorio en pacientes que han sido dados de alta del hospital |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049909 |
E.1.2 | Term | Venous thromboembolism 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 |
The primary objective is to assess the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill patients. |
El objetivo principal es evaluar la eficacia y la seguridad del rivaroxaban en comparación con placebo en la prevención del tromboembolismo venoso (TEV) sintomático y la mortalidad por TEV tras el alta hospitalaria en pacientes con procesos médicos de alto riesgo. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare rivaroxaban with placebo in the following posthospital discharge outcomes in high-risk, medically ill patients: -VTE-related death - Symptomatic VTE (lower extremity deep vein thrombosis [DVT] and non-fatal pulmonary embolism[PE]) - The composite of symptomatic VTE and all-cause mortality (ACM) - ACM |
Los objetivos secundarios son comparar el rivaroxaban con placebo en los siguientes criterios de valoración tras el alta hospitalaria en pacientes con procesos médicos de alto riesgo: - Mortalidad por TEV - TEV sintomático (trombosis venosa profunda de miembros inferiores y embolia pulmonar [EP] no mortal) - Criterio compuesto de TEV sintomático y mortalidad por todas las causas - Mortalidad por todas las causas |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
As part of protocol RIVAROXDVT3002, an optional pharmacokinetic sub-study will be conducted. The objective of the sub-study is to assess the kinetics of rivaroxaban in high-risk, medically ill patients, to describe drug exposure based on CrCl. |
Como parte del estudio RIVAROXDVT3002, un sub-estudio opcional de farmacocinética se llevará a cabo. el objetivo del sub-estudio es evaluar la cinética de rivaroxaban in pacientes con procesos médicos de alto riesgo, a fin de describir la exposición al fármaco en función del aclaramiento de creatinina (CrCl). |
|
E.3 | Principal inclusion criteria |
- Must be hospitalized at least 3 consecutive days and up to 14 days for an acute medical condition such as congestive heart failure, acute respiratory insufficiency or acute exacerbation of chronic obstructive pulmonary disease, acute ischemic stroke, acute infectious diseases or inflammatory diseases, including rheumatic disease - Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score >=3 |
- Deben haber sido hospitalizados durante un mínimo de 3 días consecutivos y hasta un máximo de 14 días por un procesos médicosagudo tal como Insuficiencia cardiaca congestiva, Insuficiencia respiratoria aguda o exacerbación aguda de una enfermedad pulmonar obstructiva crónica (EPOC), Ictus isquémico agudo, enfermedades infecciosas - Debe cumplir el criterio de TEV con una puntuación total de riesgo de TEV del IMPROVE modificada >=3 |
|
E.4 | Principal exclusion criteria |
- Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization - Serious trauma within 4 weeks before randomization - History of hemorrhagic stroke at any time in the past -Severe head trauma within 3 months of randomization - Any medical condition that requires chronic use of any parenteral or oral anticoagulation |
- Hemorragia grave en el plazo de los 3 meses anteriores a la aleatorización o que se produzca durante la hospitalización índice. - Traumatismo grave en el plazo en las 4 semanas anteriores a la aleatorización. - Traumatismo craneoencefálico grave en un plazo de 3 meses respecto a la aleatorización. - Todo proceso médico que precise el uso crónico de cualquier anticoagulante parenteral u oral |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome is the composite of all symptomatic VTE events (lower extremity DVT, non-fatal PE) and VTE-related death. |
El criterio principal de valoración de la eficacia es el criterio compuesto de todos los acontecimientos de TEV sintomático (trombosis venosa profunda en miembros inferiores, embolia pulmonar no mortal) y mortalidad por TEV. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From randomization up to day 45 |
Desde la aleatorización hasta el día 45 |
|
E.5.2 | Secondary end point(s) |
The secondary objectives are to compare rivaroxaban with placebo in the following posthospital discharge outcomes in high-risk, medically ill patients: - VTE-related death - Symptomatic VTE (lower extremity deep vein thrombosis [DVT] and non-fatal pulmonary embolism [PE]) - The composite of symptomatic VTE and all-cause mortality (ACM) - ACM |
Los objetivos secundarios son comparar el rivaroxaban con placebo en los siguientes criterios de valoración tras el alta hospitalaria en pacientes con procesos médicos de alto riesgo: - Mortalidad por TEV - TEV sintomático (trombosis venosa profunda de miembros inferiores y embolia pulmonar no mortal) - Criterio compuesto de TEV sintomático y mortalidad por todas las causas - Mortalidad por todas las causas |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From randomization up to day 45 |
Desde la aleatorización hasta el día 45 |
|
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 | Yes |
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 | Yes |
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 | 34 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 315 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Bulgaria |
Canada |
Colombia |
Czech Republic |
Denmark |
France |
Greece |
Hungary |
Israel |
Italy |
Lithuania |
Netherlands |
Poland |
Romania |
South Africa |
Spain |
Turkey |
United States |
|
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
|
LVLS |
Última visita del último paciente |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |