Clinical trial NCT02556203: Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
Official title: Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Transcatheter Aortic Valve Replacement
Keywords: TAVR
TAVI
Transfemoral aortic valve implantation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2015-09-22
Enrollment: 1653
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: To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).

To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.


Eligibility criteria: Inclusion Criteria:

* Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve)

  * By iliofemoral or subclavian access
  * With any approved/marketed device

Exclusion Criteria:

* Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment
* Any other indication for continued treatment with any oral anticoagulant (OAC)
* Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level \< 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)
* Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure
* Clinically overt stroke within the last 3 months
* Planned coronary or vascular intervention or major surgery
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher
* Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy

Primary outcomes:
measure: Number of Participants With Death or First Thromboembolic Event (DTE)
timeFrame: Through study completion, on average 14 months
measure: Number of Participants With Death or First Thromboembolic Event (DTE)
timeFrame: Through study completion, on average 16 months
measure: Number of Participants With Primary Bleeding Event (PBE)
timeFrame: Through study completion, on average 16 months
Secondary outcomes:
measure: Number of Participants With Net-clinical Benefit
timeFrame: Through study completion, on average 16 months
measure: Number of Participants With Cardiovascular Death or Thromboembolic Event
timeFrame: Through study completion, on average 16 months
measure: Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
timeFrame: Through study completion, on average 16 months
measure: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
timeFrame: Through study completion, on average 16 months
measure: Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
timeFrame: Through study completion, on average 16 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: West Des Moines
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Morristown
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Roslyn
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Linz
country: Austria
state: Oberösterreich
city: Wels
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Genk
country: Belgium
city: Hasselt
country: Belgium
city: Liege
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Brno
country: Czechia
city: Praha 10
country: Czechia
city: Praha 4
country: Czechia
city: Aarhus N
country: Denmark
city: Copenhagen
country: Denmark
city: Odense C
country: Denmark
city: Angers
country: France
city: Brest
country: France
city: Chambray-lès-Tours
country: France
city: Lille
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Konstanz
country: Germany
state: Baden-Württemberg
city: Lahr
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Ulm
country: Germany
state: Baden-Württemberg
city: Bad Neustadt
country: Germany
state: Bayern
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Bad Nauheim
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Fulda
country: Germany
state: Hessen
city: Rotenburg A.d. Fulda
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Neuss
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Bad Segeberg
country: Germany
state: Schleswig-Holstein
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Bad Berka
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Hamburg
country: Germany
city: Bergamo
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Catania
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Rotterdam
country: Netherlands
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Tromsø
country: Norway
city: Bielsko-Biala
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Oviedo
country: Spain
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: Lugano
country: Switzerland
state: Ticino
city: Bern
country: Switzerland
city: Luzern
country: Switzerland
city: Zürich
country: Switzerland
city: Brighton
country: United Kingdom
state: East Sussex
city: Southampton
country: United Kingdom
state: Hampshire
city: Blackpool
country: United Kingdom
state: Lancashire
city: Leicester
country: United Kingdom
state: Leicestershire
city: Belfast
country: United Kingdom
state: North Ireland
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchetche D, Mollmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Wohrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.
citation: Dangas GD, Tijssen JGP, Wohrle J, Sondergaard L, Gilard M, Mollmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimaraes AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Seeger J, Tchetche D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.
citation: Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8. No abstract available.
citation: Windecker S, Tijssen J, Giustino G, Guimaraes AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.