Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
Conditions
Keywords
Aortic stenosis, TAVI, TAVR, Transcatheter aortic valve implantation, Ticagrelor, Antiplatelet reactivity
Brief summary
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following TAVI.
Interventions
DRUGTicagrelor 90 mg twice per day during three months following TAVI
DRUGAspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
Sponsors
Hospital de Meixoeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study subjects should fulfill the following 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).
Exclusion criteria
Subjects should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by a system to verify the patient's platelet reactivity (VerifyNow P2Y12 assay). | Three months after antiplatelet treatment initiation following procedure. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay. | Six hours after antiplatelet treatment initiation following procedure. |
Other
| Measure | Time frame |
|---|---|
| Assess the safety of antiplatelet monotherapy with ticagrelor compared to DAPT with aspirin and clopidogrel, with regard to the incidence of investigator-reported clinical events according to predefined criteria, including bleeding definitions. | Three months after antiplatelet treatment initiation following procedure. |
Countries
Spain
Outcome results
None listed