Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247128
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
J.M. ten Berg, St. Antonius Hospital

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE September 23, 2014
Last Update Posted Date April 30, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 19, 2014)
Pharmacoeconomics endpoint [ Time Frame: 1 year ]
Outcome measure is quality-adjusted life years
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Official Title  ICMJE Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Brief 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Aortic Valve Disease
  • Myocardial Infarction
  • Stroke
  • Bleeding
Intervention  ICMJE
  • Drug: Aspirin + clopidogrel
  • Drug: Aspirin monotherapy
  • Drug: OAC + clopicogrel
  • Drug: OAC monotherapy
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Aspirin + clopidogrel
  • 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.
    Intervention: Drug: Aspirin monotherapy
  • 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.
    Intervention: Drug: OAC + clopicogrel
  • 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.
    Intervention: Drug: OAC monotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2020)
1016
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2014)
1000
Actual Study Completion Date  ICMJE April 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Luxembourg,   Netherlands
Removed Location Countries Denmark,   Italy
 
Administrative Information
NCT Number  ICMJE NCT02247128
Other Study ID Numbers  ICMJE POPTAV006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J.M. ten Berg, St. Antonius Hospital
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jurrien M ten Berg, PhD, MD St. Antonius Hospital
Principal Investigator: Pieter R Stella, MD, PhD University Medical Center Utrecht (UMCU)
PRS Account St. Antonius Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP