E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting |
Pacientes con fibrilación auricular no valvular (NVAF, siglas en inglés) que se hayan sometido a una intervención coronaria percutánea (PCI) con colocación de endoprótesis vascular (?stent?) |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with atrial fibrillation that have a stent |
Pacientes con fibrilación auricular que tienen una endoprótesis vascular (?stent?) |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065608 |
E.1.2 | Term | Percutaneous coronary intervention |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
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 compare a dual antithrombotic treatment regimen of 110mg dabigatran etexilate twice a day (b.i.d.) plus clopidogrel or ticagrelor and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor with triple antithrombotic therapy combination of warfarin plus clopidogrel or ticagrelor plus Aspirin <= 100mg once a day (q.d.) in patients with Atrial Fibrillation (AF) that undergo a Percutaneous Coronary Intervention (PCI) with stenting. |
Comparar un tratamiento antitrombótico dual de 110mg de dabigatrán etexilato dos veces al día (b.i.d.) más clopidogrel o ticagrelor y 150mg de dabigatrán etexilato b.i.d. más clopidogrel o ticagrelor con un tratamiento antitrombótico triple de warfarina más clopidogrel o ticagrelor más aspirina <= 100mg una vez al día (q.d.) en pacientes con fibrilación auricular no valvular (NVAF) que se someten a una intervención coronaria percutánea (PCI) con colocación de stent. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
No procede |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients aged >=18 years - Patients with Non Valvular Atrial Fibrillation - Patient presenting with:
An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent or Drug Eluting Stent)
Or
Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)
- The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations. |
- Pacientes (hombres o mujeres) de edades ?18 años - Pacientes con NVAF - Paciente que presente: ? Un ACS (STEMI, NonSTEMI [NSTEMI] o angina de pecho inestable tratados con éxito1 mediante PCI y colocación de stent (BMS o DES) O ? Arteriopatía coronaria estable con al menos una lesión apta para la PCI y que haya sido tratada con éxito1mediante PCI programada2 y colocación de stent (ya sea BMS o DES) - El paciente tiene que ser capaz de dar el consentimiento informado según las guías de Buena Práctica Clínica (GCP) de la Conferencia Internacional de Armonización (ICH) y la legislación/normativa locales. |
|
E.4 | Principal exclusion criteria |
- Patients with a mechanical or biological heart valve prosthesis - Cardiogenic shock during current hospitalisation - Stroke within 1 month prior to screening visit - Patients who have had major surgery within the month prior to screening - Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated - Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit - Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening - Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation) <30mL/min at screening - Active liver disease |
- Pacientes con una prótesis valvular cardíaca mecánica o biológica - Shock cardiogénico durante la hospitalización actual - Un ictus que se haya producido en el plazo de 1 mes antes de la visita de selección - Pacientes que se hayan sometido a una intervención quirúrgica de importancia en el plazo de 1 mes antes de la selección - Hemorragia gastrointestinal (GI) en un plazo de 1 mes antes de la selección, a no ser que, según el investigador, la causa haya sido eliminada de forma permanente - Evento de hemorragia grave, incluyendo un evento de hemorragia potencialmente mortal en un plazo de 1 mes antes de la visita de selección - Anemia (hemoglobina <10g/dl) o trombocitopenia incluyendo trombocitopenia inducida por heparina (número de plaquetas <100 × 109/l) en el momento de la selección - Insuficiencia renal grave (CrCl calculado según la ecuación de Cockcroft-Gault) <30ml/min en el momento de la selección - Enfermedad hepática activa |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Time to death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE))
2: Time to first International Society of Thrombosis and Haemostasis Major Bleeding Event |
1: Tiempo hasta la muerte o hasta el primer evento trombótico (todas las muertes, infarto de miocardio, ictus/SE)
2: Tiempo hasta el primer evento de hemorragia grave (ISTH grave) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: up to 30 months
2: up to 30 months |
1: hasta 30 meses
2: hasta 30 meses |
|
E.5.2 | Secondary end point(s) |
1: Time to event for individual outcome events - All death
2: Time to event for individual outcome events - Myocardial Infarction
3: Time to event for individual outcome events - Stroke
4: Time to event for individual outcome events - SE
5: Time to event for individual outcome events - Stent Thrombosis
6: Time to event for the composite endpoint of death + MI + stroke
7: Time to event for repeated revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
8: Time to event for individual outcome events - Cardiovascular death
9: Time to event for individual outcome events - Non-cardiovascular death
10: Time to event for individual outcome events - Undetermined cause of death |
1: Tiempo hasta eventos de desenlace individuales: - Todas las muertes
2: Tiempo hasta eventos de desenlace individuales: - Infarto de miocardio (MI)
3: Tiempo hasta eventos de desenlace individuales: -Ictus
4: Tiempo hasta eventos de desenlace individuales: - Embolia sistémica (SE)
5: Tiempo hasta eventos de desenlace individuales: - Trombosis del stent
6: Tiempo hasta el evento de variable combinada de muerte + MI + ictus
7: Tiempo hasta el evento de revascularización repetida mediante PCI/CABG
8: Tiempo hasta eventos de desenlace individuales: - Muerte cardiovascular
9: Tiempo hasta eventos de desenlace individuales: - Muerte no cardiovascular
10: Tiempo hasta eventos de desenlace individuales: - Causa de muerte sin determinar |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: up to 30 months
2: up to 30 months
3: up to 30 months
4: up to 30 months
5: up to 30 months
6: up to 30 months
7: up to 30 months
8: up to 30 months
9: up to 30 months
10: up to 30 months |
1: hasta 30 meses
2: hasta 30 meses
3: hasta 30 meses
4: hasta 30 meses
5: hasta 30 meses
6: hasta 30 meses
7: hasta 30 meses
8: hasta 30 meses
9: hasta 30 meses
10: hasta 30 meses |
|
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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 212 |
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 |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Colombia |
Croatia |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Singapore |
Slovakia |
Slovenia |
Spain |
Sweden |
Taiwan |
Thailand |
Turkey |
United Kingdom |
United States |
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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
|
|
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 8 |