drugset / Trial / NCT02247128

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

NCT02247128 ↗

Phase 4 Completed 1016 enrolled St. Antonius Hospital
RandomizedParallel-groupOpen-labelPrevention

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).

Timeline

Start
2014-01
Primary completion
2020-03
Completion
2020-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg —
Comparator Clopidogrel Small molecule 75 mg —