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Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes (GALILEO)

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ClinicalTrials.gov Identifier: NCT02556203
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

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 antiplateletbased strategy, following TAVR.


Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Replacement Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Acetylsalicylic acid Drug: Clopidogrel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1644 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 16, 2015
Estimated Primary Completion Date : December 7, 2018
Estimated Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rivaroxaban + ASA
Rivaroxaban + ASA (Acetylsalicylic acid) followed by rivaroxaban alone
Drug: Rivaroxaban (Xarelto, BAY59-7939)
10 mg OD (once-daily)

Drug: Acetylsalicylic acid
75 - 100 mg OD (for first 90 days only in arm 1)

Active Comparator: ASA + Clopidogrel
ASA + Clopidogrel followed by ASA alone
Drug: Acetylsalicylic acid
75 - 100 mg OD (for first 90 days only in arm 1)

Drug: Clopidogrel
75 mg OD for first 90 days




Primary Outcome Measures :
  1. Death or first adjudicated thromboembolic event (DTE) defined as composite of all-cause death and adjudicated any stroke, MI, symptomatic valve thrombosis, PE, DVT, or non-CNS SE [ Time Frame: Up to 25 months ]
    MI: Myocardial infarction, PE: Pulmonary embolism, DVT: Deep vein thrombosis, non-CNS SE: Non-central nervous system systemic embolism

  2. Primary bleeding event defined as the composite of adjudicated life-threatening, disabling or major bleeding, classified according to the VARC definitions following the BARC classification [ Time Frame: Up to 25 months ]
    VARC:Valve academic research consortium, BARC: Bleeding academic research consortium


Secondary Outcome Measures :
  1. Composite of cardiovascular death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis or non-CNS systemic embolism [ Time Frame: Up to 25 months ]
  2. Net-clinical-benefit defined as the composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism, life threatening, disabling and major bleeds [ Time Frame: Up to 25 months ]
  3. Bleeding complications defined as any of the following: composite of TIMI major or minor bleeds, ISTH major bleeding, composite of BARC 2, 3, or 5 bleeding [ Time Frame: Up to 25 months ]
    TIMI: Thrombolysis in Myocardial Infarction, ISTH: International Society on Thrombosis and Haemostasis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556203


  Hide Study Locations
Locations
United States, California
Los Angeles, California, United States, 90048-0750
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Clearwater, Florida, United States, 33756
Jacksonville, Florida, United States, 32209
Miami, Florida, United States, 33125
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Evanston, Illinois, United States, 60201
United States, Iowa
West Des Moines, Iowa, United States, 50266
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Kansas City, Missouri, United States, 64111
United States, New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Manhasset, New York, United States, 11030-3876
New York, New York, United States, 10029
Roslyn, New York, United States, 11576
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157-1045
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Wilkes-Barre, Pennsylvania, United States, 18711-3752
United States, Texas
Houston, Texas, United States, 77030-1501
Houston, Texas, United States, 77030
Plano, Texas, United States, 75093
Temple, Texas, United States, 76508
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Charlottesville, Virginia, United States, 22908
Falls Church, Virginia, United States, 22042-3300
United States, Washington
Tacoma, Washington, United States, 98405
Austria
Linz, Oberösterreich, Austria, 4020
Wels, Oberösterreich, Austria, 4600
Graz, Steiermark, Austria, 8036
Salzburg, Austria, 5020
Wien, Austria, 1090
Wien, Austria, 1130
Wien, Austria, 1160
Belgium
Genk, Belgium, 3600
Hasselt, Belgium, 3500
Liege, Belgium, 4000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V6A 1Y6
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Newmarket, Ontario, Canada, L3Y 2P7
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal, Quebec, Canada, H1T 1C8
Czechia
Brno, Czechia, 656 91
Praha 10, Czechia, 10034
Praha 4, Czechia, 140 21
Denmark
Aarhus N, Denmark, 8200
Copenhagen, Denmark, DK-2100
Odense C, Denmark, DK-5000
France
Angers, France, 49933
Brest, France, 29609
Lille, France, 59000
Paris, France, 75014
Paris, France, 75018
Toulouse, France, 31300
Tours, France, 37044
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Konstanz, Baden-Württemberg, Germany, 78464
Lahr, Baden-Württemberg, Germany, 77033
Tübingen, Baden-Württemberg, Germany, 72076
Ulm, Baden-Württemberg, Germany, 89081
Bad Neustadt, Bayern, Germany, 97616
Erlangen, Bayern, Germany, 91054
München, Bayern, Germany, 80636
München, Bayern, Germany, 81925
Regensburg, Bayern, Germany, 93042
Bad Nauheim, Hessen, Germany, 61231
Frankfurt, Hessen, Germany, 60389
Fulda, Hessen, Germany, 36043
Rotenburg A.d. Fulda, Hessen, Germany, 36199
Hannover, Niedersachsen, Germany, 30625
Aachen, Nordrhein-Westfalen, Germany, 52074
Bonn, Nordrhein-Westfalen, Germany, 53105
Dortmund, Nordrhein-Westfalen, Germany, 44137
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Krefeld, Nordrhein-Westfalen, Germany, 47805
Köln, Nordrhein-Westfalen, Germany, 50924
Neuss, Nordrhein-Westfalen, Germany, 41464
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg, Saarland, Germany, 66424
Magdeburg, Sachsen-Anhalt, Germany, 39120
Leipzig, Sachsen, Germany, 04289
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Kiel, Schleswig-Holstein, Germany, 24105
Bad Berka, Thüringen, Germany, 99437
Berlin, Germany, 10117
Berlin, Germany, 12200
Berlin, Germany, 13353
Bremen, Germany, 28277
Hamburg, Germany, 20246
Italy
Bergamo, Lombardia, Italy, 24127
Milano, Lombardia, Italy, 20089
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20162
Catania, Sicilia, Italy, 95124
Pisa, Toscana, Italy, 56124
Padova, Veneto, Italy, 35128
Korea, Republic of
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Netherlands
Amsterdam, Netherlands, 1105 AZ
Breda, Netherlands, 4818 CK
Rotterdam, Netherlands, 3015 CE
Norway
Bergen, Norway, N-5021
Oslo, Norway, 0424
Tromsø, Norway, 9038
Poland
Bielsko-Biala, Poland, 43-316
Warszawa, Poland, 02-097
Warszawa, Poland, 04-628
Spain
Oviedo, Asturias, Spain, 33011
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Barcelona, Spain, 08036
Madrid, Spain, 28046
Málaga, Spain, 29010
Sweden
Uppsala, Sweden, 751 85
Switzerland
Basel, Basel-Stadt, Switzerland, 4056
Lugano, Ticino, Switzerland, 6900
Bern, Switzerland, 3010
Luzern, Switzerland, 6000
Zürich, Switzerland, 8091
United Kingdom
Brighton, East Sussex, United Kingdom, BN2 5BE
Southampton, Hampshire, United Kingdom, SO16 6YD
Blackpool, Lancashire, United Kingdom, FY3 8NR
Leicester, Leicestershire, United Kingdom, LE3 9QP
Belfast, North Ireland, United Kingdom, BT12 6BA
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Edinburgh, United Kingdom, EH16 4SA
London, United Kingdom, SE1 7EH
London, United Kingdom, SE5 9RS
Oxford, United Kingdom, OX9 3DU
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02556203     History of Changes
Other Study ID Numbers: 17938
2015-001975-30 ( EudraCT Number )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
TAVR
TAVI
Transfemoral aortic valve implantation

Additional relevant MeSH terms:
Clopidogrel
Aspirin
Rivaroxaban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Antipyretics