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

Primary Purpose

Aortic Valve Disease, Myocardial Infarction, Stroke

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aspirin + clopidogrel
Aspirin monotherapy
OAC + clopicogrel
OAC monotherapy
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Valve Disease focused on measuring Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Disease, Aortic Stenosis, Myocardial Infarction, Ischemic stroke, Bleeding, Thrombosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Embolism and Thrombosis, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Antithrombotic treatment, Oral anticoagulation, Warfarin, Platelet Aggregation Inhibitors, Genetic Testing, Cytochrome P450 2C19 (CYP2C19), Prostaglandin-endoperoxide synthase 2(PTGS2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Algemeen Stedelijk Ziekenhuis
  • Onze Lieve Vrouwe Ziekenhuis
  • Imelda Ziekenhuis
  • Algemeen Ziekenhuis Sint Jan
  • Ziekenhuis Oost-Limburg
  • Universitair Ziekenhuis Leuven
  • Charles university, Third Faculty of Medicine
  • National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
  • Academic Medical Centre (AMC)
  • Isala Clinics
  • St. Antonius Hospital
  • Haga Ziekenhuis
  • Medisch Spectrum Twente
  • University Medical Center
  • Universitair Medisch Centrum Leiden
  • Academic Hospital
  • University Medical Center Utrecht (UMCU)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Aspirin + Clopicogrel (Cohort A)

Aspirin monotherapy (Cohort A)

OAC + Clopicogrel (Cohort B)

OAC monotherapy (Cohort B)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Safety endpoint
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 Outcome Measures

Net-clinical benefit endpoint
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
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.

Full Information

First Posted
September 19, 2014
Last Updated
April 29, 2020
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02247128
Brief Title
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Acronym
POPular-TAVI
Official Title
Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Myocardial Infarction, Stroke, Bleeding
Keywords
Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Aortic Valve Disease, Aortic Stenosis, Myocardial Infarction, Ischemic stroke, Bleeding, Thrombosis, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Embolism and Thrombosis, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Antithrombotic treatment, Oral anticoagulation, Warfarin, Platelet Aggregation Inhibitors, Genetic Testing, Cytochrome P450 2C19 (CYP2C19), Prostaglandin-endoperoxide synthase 2(PTGS2)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1016 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin + Clopicogrel (Cohort A)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aspirin monotherapy (Cohort A)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
OAC + Clopicogrel (Cohort B)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
OAC monotherapy (Cohort B)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Aspirin + clopidogrel
Intervention Type
Drug
Intervention Name(s)
Aspirin monotherapy
Intervention Type
Drug
Intervention Name(s)
OAC + clopicogrel
Intervention Type
Drug
Intervention Name(s)
OAC monotherapy
Primary Outcome Measure Information:
Title
Safety endpoint
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Net-clinical benefit endpoint
Description
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.
Time Frame
1 year
Title
Efficacy endpoint
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Pharmacoeconomics endpoint
Description
Outcome measure is quality-adjusted life years
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cohort A 1. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jurrien M ten Berg, PhD, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pieter R Stella, MD, PhD
Organizational Affiliation
University Medical Center Utrecht (UMCU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Stedelijk Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
Onze Lieve Vrouwe Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint Jan
City
Brugge
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
Charles university, Third Faculty of Medicine
City
Prague
Country
Czechia
Facility Name
National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
City
Luxembourg
Country
Luxembourg
Facility Name
Academic Medical Centre (AMC)
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Isala Clinics
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
University Medical Center
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Universitair Medisch Centrum Leiden
City
Leiden
Country
Netherlands
Facility Name
Academic Hospital
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
University Medical Center Utrecht (UMCU)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32865376
Citation
Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30.
Results Reference
derived
PubMed Identifier
32223116
Citation
Nijenhuis VJ, Brouwer J, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Apr 30;382(18):1696-1707. doi: 10.1056/NEJMoa1915152. Epub 2020 Mar 29.
Results Reference
derived
PubMed Identifier
26920599
Citation
Nijenhuis VJ, Bennaghmouch N, Hassell M, Baan J Jr, van Kuijk JP, Agostoni P, van 't Hof A, Kievit PC, Veenstra L, van der Harst P, van den Heuvel AF, den Heijer P, Kelder JC, Deneer VH, van der Kley F, Onorati F, Collet JP, Maisano F, Latib A, Huber K, Stella PR, Ten Berg JM. Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation. Am Heart J. 2016 Mar;173:77-85. doi: 10.1016/j.ahj.2015.11.008. Epub 2015 Dec 1.
Results Reference
derived

Learn more about this trial

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

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