Clinical trial NCT02247128: Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Official title: Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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)
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2014-09-23
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety endpoint
timeFrame: 1 year
Secondary outcomes:
measure: Net-clinical benefit endpoint
timeFrame: 1 year
measure: Efficacy endpoint
timeFrame: 1 year
Other outcomes:
measure: Pharmacoeconomics endpoint
timeFrame: 1 year
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwe Ziekenhuis
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint Jan
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Prague
country: Czechia
facility: Charles university, Third Faculty of Medicine
city: Luxembourg
country: Luxembourg
facility: National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre (AMC)
state: Noord Holland
city: Zwolle
country: Netherlands
facility: Isala Clinics
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center
city: Leiden
country: Netherlands
facility: Universitair Medisch Centrum Leiden
city: Maastricht
country: Netherlands
facility: Academic Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht (UMCU)
Study officials:
affiliation: St. Antonius Hospital
name: Jurrien M ten Berg, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Utrecht (UMCU)
name: Pieter R Stella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.