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Completed

NCT Number: NCT02247128

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

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).

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Key information

Conditions

Aortic Valve Disease Aortic Valve Stenosis Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Heart Valve Diseases Hemorrhage Infarction Ischemia Ischemic Stroke Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thrombosis Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Algemeen Stedelijk Ziekenhuis, Aalst, Belgium

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cohort A
  • Patient has provided written informed consent.
  • Cohort B
  • Need for long-term oral anticoagulation;
  • Patient has provided written informed consent.

Exclusion criteria

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

Treatment and study plan

Aspirin + clopidogrel

Drug

Aspirin monotherapy

Drug

OAC + clopicogrel

Drug

OAC monotherapy

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Pharmacoeconomics endpoint

    Time frame: 1 year

    Outcome measure is quality-adjusted life years

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: POPular-TAVI

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2014
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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