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Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
Sponsor: University Hospital, Bordeaux
Summary
Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2016-05-09
Completion Date
2018-05-30
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Ticagrelor alone
180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure
Combination lysine acetylsalicylate - clopidogrel
75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure
Locations (5)
CHRU de Lille
Lille, France
APHM
Marseille, France
CHRU de Nîmes
Nîmes, France
APHP
Paris, France
CHU de Bordeaux
Pessac, France