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Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

NCT02247128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1016

Last updated 2020-04-30

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Aspirin + clopidogrel

DRUG

Aspirin monotherapy

DRUG

OAC + clopicogrel

DRUG

OAC monotherapy

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Jurrien M ten Berg, PhD, MD · St. Antonius Hospital

  • Pieter R Stella, MD, PhD · University Medical Center Utrecht (UMCU)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2020-03-31
Completion
2020-04-30

Countries

  • Belgium
  • Czechia
  • Luxembourg
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247128 on ClinicalTrials.gov