Aortic Valve Stenosis Clinical Trial
Official title:
Dual AntiPlatelet Therapies for Prevention of Periinterventional Embolic Events in Transcatheter Aortic Valve Implantation (TAVI)
TAVI is increasingly adopted as standard treatment for many subgroups of patients with
aortic stenosis. However, due to a lack of data there is yet no TAVI-specific guidance
regarding the optimum periinterventional drug regimen.
The study evaluates the effect of dual antiplatelet pretreatment on periinterventional
embolic cerebral lesions and bleeding complications in patients undergoing transfemoral
aortic valve implantation (TF-TAVI).
Patients undergoing TAVI bear a high risk of ischaemic stroke, which is an independent
predictor of mortality1. Dual antiplatelet therapy (DAPT) is recommended by current
guidelines without clear specifications on the time of initiation of treatment due to a lack
of data. While some centers initiate DAPT with aspirin and clopidogrel prior to TAVI to
reduce the rate of periinterventional embolic events, others start these medications after
the procedure.Data on antithrombotic therapy during TAVI are scarce and no randomized
evaluation has been performed to demonstrate what the best strategy is during the procedure.
Therefore, the objective of this clinical trial is to assess the efficacy of pre- versus
postoperative dual antiplatelet loading with Aspirin and Clopidogrel on volume of
periinterventional cerebral ischemic lesions as quantified by diffusion weight MRI (DW-MRI)
and neurocognitive function in patients undergoing transfemoral aortic valve replacement.
The statistical trial design assumes superiority of preloading with DAPT regarding the
primary endpoint.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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