Overview

Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial

Status:
Completed

Trial end date:
2016-03-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the prevention of major ischemic events [myocardial infarction (MI), ischemic stroke] or death without increasing the risk of major bleeding events.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborator:

Edwards Lifesciences

Treatments:

Aspirin
Clopidogrel
Ticlopidine

Criteria

Inclusion Criteria:

- Patients undergoing a TAVI procedure with the Edwards SAPIEN XT valve (transfemoral or
transapical)

Exclusion Criteria:

- Need for chronic anticoagulation treatment

- Major bleeding within the 3 months prior to the TAVI procedure

- Prior intracranial bleeding

- Drug-eluting stent implantation within the year prior to the TAVI procedure

- Allergy to clopidogrel and/or aspirin