E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
serious bleeding/surgery or procedure after treatment with dabigatran |
sangrado/operación o procedimiento graves después de tratamiento con dabigatrán |
|
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019524 |
E.1.2 | Term | Hemorrhage |
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 |
Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab. |
Evaluar la reversión del efecto anticoagulante de dabigatrán en pacientes después de la administración de idarucizumab. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate safety and the pharmacokinetcs of the idarucizumab-dabigatran complex. |
Evaluar la seguridad y la farmacocinética del complejo idarucizumab-dabigatrán. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Group A (Bleeding patients)
-- Overt bleeding judged by the physician to require a reversal agent
-- Currently taking dabigatran etexilate
-- At least 18 years of age
-- Written informed consent
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding
-- Condition requiring emergency surgery or procedure where adequate hemostasis is required. Emergency is defined as within the next 4 hours.
-- Current treatment with dabigatran
-- At least 18 years of age
-- Writen Informed consent. |
Grupo A (pacientes que tienen una hemorragia):
- Hemorragia evidente, según el criterio del médico, que requiere un agente de reversión.
- Si se está tomando actualmente dabigatrán etexilato.
- Edad ? 18 años en el momento de la inclusión.
- Consentimiento informado por escrito.
Grupo B (Pacientes que están tomando dabigatrán que puede que no padezcan hemorragia, pero que necesiten una operación quirúrgica o procedimiento intervencionista urgente debido a una condición que no sea una hemorragia):
- Una condición que requiera una operación quirúrgica urgente o procedimiento intervencionista urgente donde se requiera una hemostasia adecuada. Por urgente se entiende dentro de las próximas 4 horas.
- Si se está tomando actualmente dabigatrán etexilato.
- Edad ? 18 años en el momento de la inclusión.
- Consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
- Group A (Bleeding Patients)
-- Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
-- Patients with no clinical signs of bleeding
-- Contraindications to study medication including known hypersensitivity to the drug or its excipients.
- Group B (Patients who require emergency surgery or procedure)
-- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
-- Contraindications to study medication including known hypersensitiity to the drug or its excipients. |
Grupo A (pacientes que tienen una hemorragia):
- Pacientes con hemorragia leve (p. ej., epistaxis, hematuria) en los que sea suficiente la asistencia médica habitual.
- Pacientes sin signos clínicos de hemorragia.
- Contraindicaciones a la medicación del estudio incluyendo una hipersensibilidad conocida al fármaco o a sus excipientes.
Grupo B (Pacientes que están tomando dabigatrán que puede que no padezcan hemorragia, pero que necesiten una operación quirúrgica o procedimiento intervencionista urgente debido a una condición que no sea una hemorragia):
- Una operación quirúrgica o procedimiento intervencionista programados o en los que el riesgo de una hemorragia no controlada o inmanejable es bajo.
- Contraindicaciones a la medicación del estudio incluyendo una hipersensibilidad conocida al fármaco o a sus excipientes. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Reversal of anticoagulant effect of dabigatran |
1: Reversión del efecto anticoagulante de dabigatrán |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: up to 4 hours |
1: hasta 4 horas |
|
E.5.2 | Secondary end point(s) |
1: Minimum unbound sum (free) dabigatran
2: Reversal of dTT or ECT after the first infusion and before the start of the second
3: Reversal of aPTT
4: Reversal of TT
5: Duration of reversal
6: Occurrence of major bleeding post-surgery (for Group B only)
7: Time to cessation of bleeding (for Group A only) |
1: Suma mínima no unida (libre) de concentraciones de dabigatrán
2: Reversión de dTT o ECT después de la primera infusión y antes de iniciar la segunda infusión.
3: Reversión de aPTT
4: Reversión de TT
5: Duración de la reversión
6: Presencia de hemorragia grave (solo para el grupo B) después de la operación quirúrgica
7: Tiempo hasta el cese de la hemorragia (solo para el grupo A) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: up to 4 hours
2: up to 15 minutes
3: up to 4 hours
4: up to 4 hours
5: up to 24 hours
6: up to 24 hours
7: up to 24 hours |
1: hasta 4 horas
2: hasta 15 minutos
3: hasta 4 horas
4: hasta 4 horas
5: hasta 24 horas
6: hasta 24 horas
7: hasta 24 horas |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 183 |
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 |
Belgium |
Canada |
China |
Denmark |
France |
Ireland |
Italy |
Japan |
Netherlands |
New Zealand |
Norway |
Portugal |
Slovakia |
Sweden |
Argentina |
Australia |
Brazil |
Chile |
Colombia |
Czech Republic |
Estonia |
Finland |
Germany |
Hong Kong |
India |
Korea, Republic of |
Latvia |
Lebanon |
Spain |
Israel |
Mexico |
Poland |
Russian Federation |
Singapore |
South Africa |
Taiwan |
United Kingdom |
United States |
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 16 |