Safety profile evaluation of TICagrelor Alone compared to a combination of lysine acetylsalicylate - Clopidogrel in the context of Transcatheter Aortic Valve Implantation (TAVI)

INTERVENTION: Trade Name: Brilique 90mg Pharmaceutical Form: Coated tablet Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90‐ Trade Name: Plavix 300 mg Pharmaceutical Form: Coated tablet Other descriptive name: CLOPIDOGREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Plavix 75mg Pharmaceutical Form: Coated tablet Other descriptive name: CLOPIDOGREL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Trade Name: Kardegic 75mg Pharmaceutical Form: Powder and solvent for oral solution CAS Number: 62952‐06‐1 Other descriptive name: LYSINE ASPIRIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ CONDITION: Aortic valve stenosis Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Estimate if the ticagrelor does not lead to a less good tolerance compared with the association clopidogrel ‐ acétylsalicylate of lysine in a context of TAVI according to the combined safety criteria in 30 days of VARC‐2 (Valve Academic Research Consortium‐2) Primary end point(s): The primary outcome will use the VARC2 early safety (at 30 days) composite endpoints which combines: ; ‐ All‐cause mortality; ‐ All stroke (disabling and non‐disabling) ; ‐ Life‐threatening or disabling bleeding; ‐ Acute kidney injury—Stage 2 or 3 (including renal replacement therapy); ‐ Coronary artery obstruction requiring intervention; ‐ Major vascular complication; ‐ Valve‐related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR); Secondary Objective: ‐ Estimate independently every event of the combined criteria of the main objective as well as the rythm disorders and the conduction and the other complications relative to the TAVI according to the VARC‐2; ‐ Verify that the ticagrelor does not lead to an increase of the complication rate owed to any bleedings.; ‐ Estimate the efficacity of the therapeutic by a sub‐study named "TICTAVI Emboli" involving 100 patients (50 patients in ich groups). Timepoint(s) of evaluation of this end point: day 30 SECONDARY OUTCOME: Secondary end point(s): The secondary outcomes will involve ; •Individual analysis of each endpoint of the combined criteria, but also conduction disturbances, arrhythmias and other TAVI‐related complications as defined in VARC2 ; • Analysis of all bleeding events ; • Analysis of the biological efficiency and the silent cerebrovascular events in a sub study named «TICTAVI Emboli» involving 100 patients, 50 in each group. These patients will experience per‐procedure Doppler, brain MRI, neurologic evaluation ; Timepoint(s) of evaluation of this end point: day 30 INCLUSION CRITERIA: • Provision of informed consent prior to any study specific procedures • Female or male aged > 18 years • Patient eligible for TAVI as recommended by HAS (French health care system authority) 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 308 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 308