Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation — POPular-TAVI  

Stroke Clinical Trial

Official title: Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

Status Completed

Clinical Trial Summary

At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.

We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).

Clinical Trial Description

The trial consists of two cohorts:

• Cohort A, patients without an indication for OAC prior to TAVI.

• Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis). ;

Related Conditions & MeSH terms

• Aortic Valve Disease
• Bleeding
• Hemorrhage
• Infarction
• Myocardial Infarction
• Stroke

• NCT number: NCT02247128
• Study type: Interventional
• Source: St. Antonius Hospital
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Completion date: April 2020