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

April 29, 2020 updated by: J.M. ten Berg, St. Antonius Hospital

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).

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

1016

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalst, Belgium
        • Algemeen Stedelijk Ziekenhuis
      • Aalst, Belgium
        • Onze Lieve Vrouwe Ziekenhuis
      • Bonheiden, Belgium
        • Imelda Ziekenhuis
      • Brugge, Belgium
        • Algemeen Ziekenhuis Sint Jan
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Leuven, Belgium
        • Universitair Ziekenhuis Leuven
      • Prague, Czechia
        • Charles university, Third Faculty of Medicine
      • Luxembourg, Luxembourg
        • National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
      • Den Haag, Netherlands
        • HAGA ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands, 9700 RB
        • University Medical Center
      • Leiden, Netherlands
        • Universitair Medisch Centrum Leiden
      • Maastricht, Netherlands, 6229 HX
        • Academic Hospital
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht (UMCU)
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1105 AZ
        • Academic Medical Centre (AMC)
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8011 JW
        • Isala Clinics
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435CM
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cohort A

    1. Patient has provided written informed consent.

  • Cohort B

    1. Need for long-term oral anticoagulation;
    2. Patient has provided written informed consent.

Exclusion Criteria:

  • Cohort A

    1. Need for long-term oral anticoagulation;
    2. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    3. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    4. Allergy or intolerance to aspirin or clopidogrel.
  • Cohort B

    1. Drug-eluting stent implantation within 3 months prior to TAVI procedure;
    2. Bare-metal stent implantation within 1 month prior to TAVI procedure;
    3. Allergy or intolerance to (N)OAC or clopidogrel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aspirin + Clopicogrel (Cohort A)
Cohort A: patients will receive clopidogrel (75mg quaque die (qD), 3 months) on top of low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patient in Cohort A doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI.
Active Comparator: Aspirin monotherapy (Cohort A)
Cohort A: patients will receive low-dose aspirin (≤100mg qD, at least 1 year but recommended lifelong). When a patients doesn't already takes aspirin, a loading dose of 300mg will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.
Active Comparator: OAC + Clopicogrel (Cohort B)
Cohort B: patients will receive clopidogrel (75mg qD, 3 months) on top of OAC (according to its indication). The loading dose for clopidogrel is 300mg, and will be given within 24 hours prior to TAVI. It is recommended to omit other antiplatelet therapy (e.g. aspirin) at least 5 days prior to the TAVI procedure.
Active Comparator: OAC monotherapy (Cohort B)
Cohort B: patients will receive OAC according to its indication. It is recommended to continue the OAC therapy peri-procedural (International Normalized Ratio aimed at 2.0). It is recommended to omit antiplatelet therapy (e.g. clopidogrel) at least 5 days prior to the TAVI procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoint
Time Frame: 1 year
The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net-clinical benefit endpoint
Time Frame: 1 year
The secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI.
1 year
Efficacy endpoint
Time Frame: 1 year
The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacoeconomics endpoint
Time Frame: 1 year
Outcome measure is quality-adjusted life years
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jurrien M ten Berg, PhD, MD, St. Antonius Hospital
  • Principal Investigator: Pieter R Stella, MD, PhD, University Medical Center Utrecht (UMCU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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