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Aortic Valve DiseasePhase 4POPular-TAVINCT02247128

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

A Phase 4 study testing Aspirin + clopidogrel, Aspirin monotherapy and OAC + clopicogrel in people with Aortic Valve Disease and Myocardial Infarction, run by St. Antonius Hospital at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin + clopidogrel, Aspirin monotherapy and OAC + clopicogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,016 participants
Where
17 sitesin 4 countries
Study dates
Jan 2014to Apr 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Netherlands9 sites

  • Academic Medical Centre (AMC)

    Amsterdam, North Holland, 1105 AZ

  • Medisch Spectrum Twente

    Enschede

  • University Medical Center

    Groningen, 9700 RB

  • Universitair Medisch Centrum Leiden

    Leiden

  • Academic Hospital

    Maastricht, 6229 HX

  • St. Antonius Hospital

    Nieuwegein, Utrecht, 3435CM

  • Haga Ziekenhuis

    The Hague

  • University Medical Center Utrecht (UMCU)

    Utrecht, 3584 CX

  • Isala Clinics

    Zwolle, Overijssel, 8011 JW

Other trials in Netherlands

Belgium6 sites

  • Algemeen Stedelijk Ziekenhuis

    Aalst

  • Onze Lieve Vrouwe Ziekenhuis

    Aalst

  • Imelda Ziekenhuis

    Bonheiden

  • Algemeen Ziekenhuis Sint Jan

    Bruges

  • Ziekenhuis Oost-Limburg

    Genk

  • Universitair Ziekenhuis Leuven

    Leuven

Other trials in Belgium

Czechia1 site

  • Charles university, Third Faculty of Medicine

    Prague

Other trials in Czechia

Luxembourg1 site

  • National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle

    Luxembourg

Other trials in Luxembourg

About this study

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).

Read the 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).
Being tested
Aspirin + clopidogrel, Aspirin monotherapy, OAC + clopicogrel, OAC monotherapy
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
Medical subject headings
Aortic Valve Disease, Myocardial Infarction, Stroke, Hemorrhage, Aortic Valve Stenosis, Ischemic Stroke, Thrombosis, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspirin + clopidogrelDrug

  • Aspirin monotherapyDrug

  • OAC + clopicogrelDrug

  • OAC monotherapyDrug

Study groups in NCT02247128
Study groupRoleWhat they receive
Aspirin + Clopicogrel (Cohort A)Active comparatorCohort 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.
Receives: Drug: Aspirin + clopidogrel
Aspirin monotherapy (Cohort A)Active comparatorCohort 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.
Receives: Drug: Aspirin monotherapy
OAC + Clopicogrel (Cohort B)Active comparatorCohort 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.
Receives: Drug: OAC + clopicogrel
OAC monotherapy (Cohort B)Active comparatorCohort 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.
Receives: Drug: OAC monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 year

Secondary outcomes (2)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2020
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,016 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247128
Sponsor's protocol ID
POPTAV006
Acronym
POPular-TAVI
Status last verified
Apr 2020
First submitted
19 Sep 2014
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32865376

  • 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.

    PubMed 32223116

  • 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.

    PubMed 26920599

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin + clopidogrel, Aspirin monotherapy and OAC + clopicogrel in people with Aortic Valve Disease and Myocardial Infarction, run by St. Antonius Hospital at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Netherlands, Belgium, Czechia, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247128, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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