Platelet reactivity after TAVI: A multicenter randomized clinical trial

INTERVENTION: Trade Name: BRILIQUE Product Name: Ticagrelor Pharmaceutical Form: Tablet Trade Name: DUOPLAVIN Pharmaceutical Form: Tablet CONDITION: Study platelet reactivity in patients with Aortic Stenosis (AS) selected for TAVI and to assess the effectiviness of ticagrelor as antiplatelet monotherapy for the supression of high platelet reactivity after TAVI, compared with current standard DAPT with ASA plus clopidogrel. Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To evaluate the effectiviness of ticagrelor compared to clopidogrel and aspirin for the supression of res¡dual platelet reactivity by VeryNow P2Y12 assay 90 days after TAVI Primary end point(s): Efficacy endpoint: Achievement of residual platelet reactivity with Verify Now P2Y12 of PRU <208 in ? 70 % of patients treated with ticagrelor (or a net difference between groups of 40 %) after three months of antiplatelet initiation following TAVI procedure. Secondary Objective: Compare the proportion of patients with high on treatment platelet reactivity before TAVI and after 6hrs, 24 hrs, 5 days, 30 days, and 90 days of antiplatelet treatment initiation post‐TAVI. Timepoint(s) of evaluation of this end point: 90 days after TAVI SECONDARY OUTCOME: Secondary end point(s): Proportion of patients with high on treatment platelet reactivity as measured by Verify Now P2Y12 assay after 6 hours of antiplatelet treatment iniciated post TAVI, achieving the lower prevalence of high on treatment pletelet reactivity patients in the group treated with ticagrelor compared with clopidogrel (net difference between groups of 30%). Timepoint(s) of evaluation of this end point: Evaluate patients with high on treatment platelet reactivity at 6 hours, 24 hours, 5 days, 30 days and 90 days after TAVI. INCLUSION CRITERIA: 1. Provision of informed consent prior to any study specific procedures. 2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial. 3. Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center. 4. Patients who are not participating in any other clinical trial or research study (registries allowed). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60