E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with severe aortic stenosis submitted for Transcatheter Aortic Valve Implantation |
Pacientes con estenosis aórtica grave sometidos a implante de válvula aórtica transcatéter |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with severely narrow aortic valve who undergo replacement through catheters. |
Pacientes con la válvula aórtica severamente estrecha que se sometan a un recambio a través de catéteres. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 efficacy of available dose of Ticagrelor 60 mg/12h in suppressing high platelet reactivity after TAVI. |
La eficacia de la dosis disponible de Ticagrelor 60 mg / 12 h en la supresión de la alta reactividad plaquetaria después de TAVI. |
|
E.2.2 | Secondary objectives of the trial |
The incidence of hemorrhagic complications |
Determinar la incidencia de complicaciones hemorrágicas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- >18 years old - Diagnosed with severe aortic stenosis - High and/or intermediate surgery risk based on current risk scores - Ruled in by a Heart Team decision - Without previous dual antiplatelet therapy - Plaqueted reactivity made by VerifyNow® assays in whom has been treated with Clopidogrel |
-> 18 años - Diagnosticado con estenosis aórtica severa - Riesgo alto y / o intermedio de cirugía según las puntuaciones de riesgo actuales - Decisión del Equipo mutidisciplinar - Sin terapia antiplaquetaria doble previamente - Reactividad plaquetaria realizada por prueba VerifyNow® en quienes están con tratamiento con Clopidogrel |
|
E.4 | Principal exclusion criteria |
- Contraindication to TAVI - Atrial Fibrillation (which needs oral anticoagulation) - Oral anticoagulation - History of intracranial hemorrhage - Ischemic stroke the 14 days before TAVI - Active pathological bleeding or diathesis - Moderate to severe hepatic impairment - Use of strong CYP34A inhibitors or inducers - Use of ISRS (Paroxetina, Sertralina, Citalopram) - Contraindications to DAPT for 3 months - Contraindication to Aspirin, clopidogrel or ticagrelor - Platelet count <50.000 - Pregnancy or breastfeeding |
- Contraindicación para TAVI - Fibrilación auricular (que necesita anticoagulación oral) - Anticoagulación oral - Historia de hemorragia intracraneal - Accidente cerebrovascular isquémico los 14 días antes de TAVI - Sangrado o diátesis patológica activa - Insuficiencia hepática moderada a severa - Uso de inhibidores o inductores potentes de CYP34A - Uso de ISRS (Paroxetina, Sertralina, Citalopram) - Contraindicaciones para doble antiagregación plaquetaria durante 3 meses. - Contraindicación a la aspirina, clopidogrel o ticagrelor - Recuento de plaquetas <50,000 - Embarazo o lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assess the efficacy of ticagrelor 60 mg/12h in suppressing HPR after TAVI |
Determinar la eficacia del ticagrelor 60 mg/12h en la supresión de la alta reactividad plaquetaria después de la TAVI |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Pre-TAVI: 2. In-Hospital after TAVI: at 24 ± 2hrs 3. Out-of-Hospital follow-up visits : at 30 ± 7 days at 90 ± 7 days at 120 ± 7 days |
1. Pre-TAVI: 2. I24 ± 2hrs tras la implantación de la TAVI 3. Al alta hospitalaria: A los 30 ± 7 días, a los 90 ± 7 días y a los 120 ± 7 días |
|
E.5.2 | Secondary end point(s) |
Evaluate the incidence of hemorrhagic complications after TAVI. |
Evaluar la incidencia de complicaciones hemorrágicas después de la TAVI |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Pre-TAVI 2. In-Hospital after TAVI: at 24 ± 2hrs 3. Out-of-Hospital follow-up visits : at 30 ± 7 days at 90 ± 7 days at 120 ± 7 days |
1. Pre-TAVI: 2. I24 ± 2hrs tras la implantación de la TAVI 3. Al alta hospitalaria: A los 30 ± 7 días, a los 90 ± 7 días y a los 120 ± 7 días |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | 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 | 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 | 3 |
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 | No |
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
|
The last visit is 120 day after TAVI |
La ultima visita del estudio será 120 días después de la TAVI |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |