Aortic valve stenosis
Conditions
Interventions
Trade Name: Brilique 90mg
Pharmaceutical Form: Coated tablet
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Conc
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • Allergy, hypersensitivity, or contraindication to lysine acetylsalicylate, clopidogrel, ticagrelor, any anticoagulation or MRI or CT-scanner contrast agents • Use of CYP3a inhibitor (Cf. Table below) • Need for chronic anticoagulation • Previous percutaneous coronary intervention or acute coronary syndrome requiring dual antiplatelet therapy • Previous cardiac surgery for valve replacement • Prior stroke, TIA or known carotid stenosis > 70% • Active pathological bleeding or gastric ulcer < 3month • Known thrombocytopenia, anemia or any coagulopathy • Severe kidney or hepatic impairment • Hemodynamic instability • Refusal of Transfusion • Significant mental impairment • Inability to give informed consent or comply with study related procedures or high likelihood of being unavailable for follow-up • Pregnant or breastfeeding women • Women of childbearing potential without effective contraception (oetroprogestatifs, intrauterine devices) • Participant in another investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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); 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). ; 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) ;Timepoint(s) of evaluation of this end point: day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
Public ContactREC
CHU de Bordeaux
Outcome results
None listed