Symptomatic severe aortic stenosis MedDRA version: 20.0 Level: LLT Classification code 10077017 Term: TAVI System Organ Class: 100000004865 MedDRA version: 20.0 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.1 Level: PT Classification code 10002906 Term: Aortic stenosis System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Ticagrelor 60 mg
Product Name: Ticagrelor 60mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
CAS Number: 274693-27-5
Other descriptive name: TICAGRELOR
Concentration unit: mg
Sponsors
Fundación Biomédica Galicia Sur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provisión de consentimiento informado antes de cualquier procedimiento específico del estudio. 2) Pacientes adultos (mayores de 18 años) con capacidad para comprender y aceptar la participación en el ensayo clínico. 3) Pacientes con EA degenerativa sintomática grave aceptados para TAVI con cualquiera de los dispositivos TAVI comercialmente aprobados después de la evaluación del Heart Team de cada centro, y con al menos una de las siguientes comorbilidades: • Diabetes Mellitus, deben mantenerse los criterios diagnósticos actuales de la OMS para la diabetes: glucosa plasmática en ayunas = 7,0 mmol / l (126 mg / dl) o glucosa plasmática a las 2 h = 11,1 mmol / l (200 mg / dl), o en tratamiento con un hipoglucemiante oral o insulina • Enfermedad arterial coronaria previa (STEMI, NSTEMI, angina estable u otras) documentada mediante pruebas de detección de isquemia invasivas o no invasivas o estudios de imágenes • Enfermedad arterial periférica previa documentada mediante pruebas de detección de isquemia invasivas o no invasivas o estudios de imágenes. 4) TAVI exitoso realizado por cualquier acceso vascular. 5) Pacientes que no están participando en ningún otro ensayo clínico o estudio de investigación (registros permitidos). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1196
Exclusion criteria
Exclusion criteria: 1) Patients under chronic oral anticoagulation for any specific pathology 2)Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI 3) History of overt major bleeding or intracranial hemorrhage 4) Active pathological bleeding 5) History of ischemic stroke within the last 30 days prior TAVI 6) Patients with documented severe hepatic insufficiency 7) Known pregnancy, breast-feeding, or intend to become pregnant during the study period 8) Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study. Section 13.1 Ticagrelor Overdose: any dose over the clinically intended dose. 9) Patients randomized in another clinical trial with an investigational product or device over the past 30 days 10) Patients who cannot attend follow-up visits scheduled in the study. 11) History of allergic reactions or intolerance to Ticagrelor orAspirin or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare two SAPT strategies: Aspirin 100mg once per day versus Ticagrelor 60 mg twice per day as antiplatelet treatment for the prevention of net adverse clinical events (NACE) following a successful TAVI;Secondary Objective: •Key secondary efficacy endpoint: Subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion(RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4D-CT) imaging (performed only in pre-specified centers). •Key secondary safety endpoint: Major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC (Bleeding Academic Research Consortium). •Complementary secondary endpoints: Patient-oriented composite endpoints (POCE) at 12 months after TAVI (POCE is a composite of all-cause mortality,TIA/stroke, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography). Individual components of NACE at 12 months after TAVI;Primary end point(s): Incidence of NACE (All-cause mortality, Transient ischemic attack (TIA) or stroke, Myocardialinfarction, Progressive angina leading to emergency evaluation,rehospitalization or new coronary angiography, Valve thrombosis, Claudication, Acute limb ischemia leading to hospitalization, Any bleeding);Timepoint(s) of evaluation of this end point: At 12 months after TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Subclinical valve thrombosis (SVT) 2) Major bleeding (type 2, 3 and 5) according BARC (Bleeding Academic Research Consortium). 3) Patient-oriented composite endpoints (POCE) after TAVI (POCE is a composite of all-cause mortality,TIA/stroke, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography);Timepoint(s) of evaluation of this end point: 1) 180 ± 7 days and 365 ± 14 days 2) At 12 months after TAVI 3) At 12 months after TAVI | — |
Countries
Spain
Contacts
Public ContactCardiovascular Research Unit
Hospital Alvaro Cunqueiro
Outcome results
None listed