drugset / Trial / NCT02817789

Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)

NCT02817789

Phase 3 Terminated 50 enrolled University Hospital, Bordeaux
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2016-05-09
Primary completion
2018-05-30
Completion
2018-05-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg
Subject Ticagrelor Small molecule 90 mg
Comparator lysine acetylsalicylate Unknown 75 mg

Indications