Study Stopped
Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
GALILEO
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
2 other identifiers
interventional
1,653
17 countries
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
Typical duration for phase_3
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedStudy Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedResults Posted
Study results publicly available
January 13, 2020
CompletedJanuary 13, 2020
December 1, 2019
3 years
September 5, 2015
November 22, 2019
December 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Death or First Thromboembolic Event (DTE)
Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.
Through study completion, on average 14 months
Number of Participants With Death or First Thromboembolic Event (DTE)
Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.
Through study completion, on average 16 months
Number of Participants With Primary Bleeding Event (PBE)
PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.
Through study completion, on average 16 months
Secondary Outcomes (5)
Number of Participants With Net-clinical Benefit
Through study completion, on average 16 months
Number of Participants With Cardiovascular Death or Thromboembolic Event
Through study completion, on average 16 months
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
Through study completion, on average 16 months
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
Through study completion, on average 16 months
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
Through study completion, on average 16 months
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALSubjects 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.
Antiplatelet
ACTIVE COMPARATORSubjects 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.
Interventions
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (140)
Unknown Facility
Los Angeles, California, 90048-0750, United States
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Washington D.C., District of Columbia, 20010, United States
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Clearwater, Florida, 33756, United States
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Jacksonville, Florida, 32209, United States
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Miami, Florida, 33136, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Evanston, Illinois, 60201, United States
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West Des Moines, Iowa, 50266, United States
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Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48202, United States
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Minneapolis, Minnesota, 55407, United States
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Kansas City, Missouri, 64111, United States
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Morristown, New Jersey, 07962, United States
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Manhasset, New York, 11030-3876, United States
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New York, New York, 10029, United States
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Roslyn, New York, 11576, United States
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Winston-Salem, North Carolina, 27157-1082, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44195, United States
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Philadelphia, Pennsylvania, 19104, United States
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Wilkes-Barre, Pennsylvania, 18711-3752, United States
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Houston, Texas, 77030-1501, United States
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Houston, Texas, 77030, United States
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Plano, Texas, 75093, United States
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Temple, Texas, 76508, United States
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Burlington, Vermont, 05401, United States
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Charlottesville, Virginia, 22908, United States
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Falls Church, Virginia, 22042-3300, United States
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Tacoma, Washington, 98405, United States
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Graz, Styria, 8036, Austria
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Linz, Upper Austria, 4020, Austria
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Wels, Upper Austria, 4600, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Vienna, 1160, Austria
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Genk, 3600, Belgium
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Hasselt, 3500, Belgium
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Liège, 4000, Belgium
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Edmonton, Alberta, T6G 2B7, Canada
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Vancouver, British Columbia, V6A 1Y6, Canada
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Victoria, British Columbia, V8R 4R2, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Newmarket, Ontario, L3Y 2P7, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Brno, 656 91, Czechia
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Prague, 10034, Czechia
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Prague, 140 21, Czechia
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Aarhus N, 8200, Denmark
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Copenhagen, DK-2100, Denmark
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Odense C, DK-5000, Denmark
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Angers, 49100, France
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Brest, 29609, France
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Chambray-lès-Tours, 37170, France
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Lille, 59000, France
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Paris, 75014, France
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Paris, 75018, France
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Toulouse, 31300, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Konstanz, Baden-Wurttemberg, 78464, Germany
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Lahr, Baden-Wurttemberg, 77033, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Ulm, Baden-Wurttemberg, 89081, Germany
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Bad Neustadt an der Saale, Bavaria, 97616, Germany
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Erlangen, Bavaria, 91054, Germany
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München, Bavaria, 80331, Germany
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München, Bavaria, 80636, Germany
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München, Bavaria, 81925, Germany
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Regensburg, Bavaria, 93042, Germany
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Bad Nauheim, Hesse, 61231, Germany
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Frankfurt am Main, Hesse, 60389, Germany
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Fulda, Hesse, 36043, Germany
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Rotenburg A.d. Fulda, Hesse, 36199, Germany
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Hanover, Lower Saxony, 30625, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Bonn, North Rhine-Westphalia, 53105, Germany
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Cologne, North Rhine-Westphalia, 50924, Germany
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Dortmund, North Rhine-Westphalia, 44137, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Krefeld, North Rhine-Westphalia, 47805, Germany
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Neuss, North Rhine-Westphalia, 41464, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66424, Germany
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Leipzig, Saxony, 04289, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Bad Segeberg, Schleswig-Holstein, 23795, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Bad Berka, Thuringia, 99437, Germany
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Berlin, 10117, Germany
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Berlin, 12200, Germany
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Berlin, 13353, Germany
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Bremen, 28277, Germany
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Hamburg, 20246, Germany
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Bergamo, Lombardy, 24127, Italy
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Milan, Lombardy, 20089, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20162, Italy
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Catania, Sicily, 95124, Italy
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Pisa, Tuscany, 56124, Italy
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Padua, Veneto, 35128, Italy
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Amsterdam, 1105 AZ, Netherlands
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Breda, 4818 CK, Netherlands
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Rotterdam, 3015 CE, Netherlands
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Bergen, N-5021, Norway
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Oslo, 0424, Norway
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Tromsø, 9038, Norway
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Bielsko-Biala, 43-316, Poland
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Warsaw, 02-097, Poland
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Warsaw, 04-628, Poland
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Barcelona, 08036, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Uppsala, 751 85, Sweden
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Basel, Canton of Basel-City, 4056, Switzerland
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Lugano, Canton Ticino, 6900, Switzerland
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Bern, 3010, Switzerland
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Lucerne, 6000, Switzerland
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Zurich, 8091, Switzerland
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Brighton, East Sussex, BN2 5BE, United Kingdom
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Southampton, Hampshire, SO16 6YD, United Kingdom
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Blackpool, Lancashire, FY3 8NR, United Kingdom
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Leicester, Leicestershire, LE3 9QP, United Kingdom
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Belfast, North Ireland, BT12 6BA, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
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Leeds, West Yorkshire, LS1 3EX, United Kingdom
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Edinburgh, EH16 4SA, United Kingdom
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London, SE1 7EH, United Kingdom
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London, SE5 9RS, United Kingdom
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Oxford, OX9 3DU, United Kingdom
Related Publications (5)
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.
PMID: 36040717DERIVEDWohrle 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.
PMID: 35934563DERIVEDDangas 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.
PMID: 31733180DERIVEDPiayda 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.
PMID: 29536857DERIVEDWindecker 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.
PMID: 27892890DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 22, 2015
Study Start
December 16, 2015
Primary Completion
November 27, 2018
Study Completion
November 27, 2018
Last Updated
January 13, 2020
Results First Posted
January 13, 2020
Record last verified: 2019-12