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.
Conditions
Interventions
Trade Name: BRILIQUE
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
Trade Name: DUOPLAVIN
Pharmaceutical Form: Tablet
Sponsors
Sociedad Española de Cardiología
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Recent stroke 70% stenosis) or life expectancy < 12 months 2. Patients under chronic oral anticoagulation 3.Patients with proven allergy to aspirin, clopidogrel or ticagrelor 4.Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication Known pregnancy or breast-feeding 5. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not azitromicine), nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, and more than a daily liter of grapefruit juice. 6. Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant. 7. Patients with documented moderate or severe hepatic insufficiency 8. Any condition that may put the patient at risk or influence the outcome of the trial 9. Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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.;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.;Timepoint(s) of evaluation of this end point: 90 days after TAVI | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactUNICA Vigo
Cardiovascular Research Unit Vigo
Outcome results
None listed