NCT02247128

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,016 (actual)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Aortic Valve Disease
• Myocardial Infarction
• Stroke
• Bleeding

Interventions

Type	Name	Description
DRUG	Aspirin + clopidogrel
DRUG	Aspirin monotherapy
DRUG	OAC + clopicogrel
DRUG	OAC monotherapy

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-03-01
• Completion: 2020-04-01
• First posted: 2014-09-23
• Last updated: 2020-04-30

Locations

17 sites across 4 countries: Belgium, Czechia, Luxembourg, Netherlands