Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
NCT ID: NCT02556203
Last Updated: 2020-01-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
1653 participants
INTERVENTIONAL
2015-12-16
2018-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
NCT03374540
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
NCT02064439
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
NCT01674647
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
NCT02504216
Xarelto Regulatory Post-Marketing Surveillance
NCT01029743
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rivaroxaban (Xarelto, BAY59-7939)
Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
Rivaroxaban (Xarelto, BAY59-7939)
10mg OD (once-daily)
Acetylsalicylic Acid (ASA)
75-100mg OD
Rivaroxaban (Xarelto, BAY59-7939)
In case of NOAF, 20/15 mg OD (once-daily)
Antiplatelet
Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Acetylsalicylic Acid (ASA)
75-100mg OD
Clopidogrel
75mg OD
Vitamin K antagonist (VKA)
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rivaroxaban (Xarelto, BAY59-7939)
10mg OD (once-daily)
Acetylsalicylic Acid (ASA)
75-100mg OD
Clopidogrel
75mg OD
Rivaroxaban (Xarelto, BAY59-7939)
In case of NOAF, 20/15 mg OD (once-daily)
Vitamin K antagonist (VKA)
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* By iliofemoral or subclavian access
* With any approved/marketed device
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
West Des Moines, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Morristown, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
Roslyn, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
Houston, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Temple, Texas, United States
Burlington, Vermont, United States
Charlottesville, Virginia, United States
Falls Church, Virginia, United States
Tacoma, Washington, United States
Graz, Styria, Austria
Linz, Upper Austria, Austria
Wels, Upper Austria, Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Genk, , Belgium
Hasselt, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Brno, , Czechia
Prague, , Czechia
Prague, , Czechia
Aarhus N, , Denmark
Copenhagen, , Denmark
Odense C, , Denmark
Angers, , France
Brest, , France
Chambray-lès-Tours, , France
Lille, , France
Paris, , France
Paris, , France
Toulouse, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Konstanz, Baden-Wurttemberg, Germany
Lahr, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Bad Neustadt an der Saale, Bavaria, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Bad Nauheim, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Fulda, Hesse, Germany
Rotenburg A.d. Fulda, Hesse, Germany
Hanover, Lower Saxony, Germany
Aachen, North Rhine-Westphalia, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Krefeld, North Rhine-Westphalia, Germany
Neuss, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Bad Segeberg, Schleswig-Holstein, Germany
Kiel, Schleswig-Holstein, Germany
Bad Berka, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Bremen, , Germany
Hamburg, , Germany
Bergamo, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Catania, Sicily, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Amsterdam, , Netherlands
Breda, , Netherlands
Rotterdam, , Netherlands
Bergen, , Norway
Oslo, , Norway
Tromsø, , Norway
Bielsko-Biala, , Poland
Warsaw, , Poland
Warsaw, , Poland
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
L'Hospitalet de Llobregat, Barcelona, Spain
Oviedo, Principality of Asturias, Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Uppsala, , Sweden
Basel, Canton of Basel-City, Switzerland
Lugano, Canton Ticino, Switzerland
Bern, , Switzerland
Lucerne, , Switzerland
Zurich, , Switzerland
Brighton, East Sussex, United Kingdom
Southampton, Hampshire, United Kingdom
Blackpool, Lancashire, United Kingdom
Leicester, Leicestershire, United Kingdom
Belfast, North Ireland, United Kingdom
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Leeds, West Yorkshire, United Kingdom
Edinburgh, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Wohrle J, Gilard M, Didier R, Kini A, Tavenier AH, Tijssen JGP, Sartori S, Snyder C, Nicolas J, Seeger J, Landmesser U, Tarantini G, Asgar A, Mollmann H, Thiele H, Capranzano P, Reimers B, Stefanini G, Moreno R, Petronio AS, Mikhail G, Kapadia S, Hildick-Smith D, Hengstenberg C, Mehran R, Windecker S, Dangas GD; GALILEO Investigator. Outcomes After Transcatheter Aortic Valve Implantation in Men Versus Women. Am J Cardiol. 2022 Oct 1;180:108-115. doi: 10.1016/j.amjcard.2022.06.035. Epub 2022 Aug 4.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find results for studies related to Bayer products
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-001975-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17938
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.