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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)

This study is currently recruiting participants.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02556203
First Posted: September 22, 2015
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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

  • 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:
  • 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 ]
  • 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 ]
  • 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


Estimated Enrollment: 1520
Actual Study Start Date: December 16, 2015
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
United States, Alabama
Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, California
Terminated
La Jolla, California, United States, 92037
Terminated
Los Angeles, California, United States, 90027
Active, not recruiting
Los Angeles, California, United States, 90048-0750
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Active, not recruiting
Clearwater, Florida, United States, 33756
Active, not recruiting
Jacksonville, Florida, United States, 32209
Active, not recruiting
Miami, Florida, United States, 33125
United States, Georgia
Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States, 60611
Active, not recruiting
Evanston, Illinois, United States, 60201
Terminated
Springfield, Illinois, United States, 62769
United States, Iowa
Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Louisiana
Terminated
New Orleans, Louisiana, United States, 70121
United States, Maryland
Active, not recruiting
Baltimore, Maryland, United States, 21201
Terminated
Baltimore, Maryland, United States, 21287-6568
United States, Massachusetts
Not yet recruiting
Boston, Massachusetts, United States, 02115-6195
Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Active, not recruiting
Minneapolis, Minnesota, United States, 55407
Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Active, not recruiting
Kansas City, Missouri, United States, 64111
Terminated
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Active, not recruiting
Morristown, New Jersey, United States, 07962
United States, New York
Terminated
Albany, New York, United States, 12208
Not yet recruiting
Liverpool, New York, United States, 13088
Active, not recruiting
Manhasset, New York, United States, 11030-3876
Terminated
New York, New York, United States, 10016-4576
Recruiting
New York, New York, United States, 10029
Terminated
New York, New York, United States, 10032
Not yet recruiting
Rochester, New York, United States, 14642
Active, not recruiting
Roslyn, New York, United States, 11576
Not yet recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Active, not recruiting
Winston-Salem, North Carolina, United States, 27157-1045
United States, Ohio
Active, not recruiting
Cincinnati, Ohio, United States, 45219
Active, not recruiting
Cleveland, Ohio, United States, 44195
Terminated
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Terminated
Danville, Pennsylvania, United States, 17822-2001
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Active, not recruiting
Wilkes-Barre, Pennsylvania, United States, 18711-3752
United States, Texas
Recruiting
Houston, Texas, United States, 77030-1501
Active, not recruiting
Houston, Texas, United States, 77030
Active, not recruiting
Plano, Texas, United States, 75093
Active, not recruiting
Temple, Texas, United States, 76508
United States, Vermont
Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Active, not recruiting
Charlottesville, Virginia, United States, 22908
Active, not recruiting
Falls Church, Virginia, United States, 22042-3300
Terminated
Richmond, Virginia, United States, 23226-1907
United States, Washington
Active, not recruiting
Tacoma, Washington, United States, 98405
Austria
Active, not recruiting
Linz, Oberösterreich, Austria, 4020
Active, not recruiting
Wels, Oberösterreich, Austria, 4600
Active, not recruiting
Graz, Steiermark, Austria, 8036
Active, not recruiting
Salzburg, Austria, 5020
Active, not recruiting
Wien, Austria, 1090
Active, not recruiting
Wien, Austria, 1130
Active, not recruiting
Wien, Austria, 1160
Belgium
Active, not recruiting
Genk, Belgium, 3600
Active, not recruiting
Hasselt, Belgium, 3500
Active, not recruiting
Liege, Belgium, 4000
Canada, Alberta
Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Active, not recruiting
Vancouver, British Columbia, Canada, V6A 1Y6
Active, not recruiting
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
Active, not recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Terminated
Saint John, New Brunswick, Canada, E2L 4M2
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Active, not recruiting
Newmarket, Ontario, Canada, L3Y 2P7
Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Active, not recruiting
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada, H1T 1C8
Czechia
Active, not recruiting
Brno, Czechia, 656 91
Terminated
Olomouc, Czechia, 775 20
Active, not recruiting
Praha 10, Czechia, 10034
Active, not recruiting
Praha 4, Czechia, 140 21
Denmark
Recruiting
Aarhus N, Denmark, 8200
Recruiting
Copenhagen, Denmark, DK-2100
Recruiting
Odense C, Denmark, DK-5000
France
Active, not recruiting
Angers, France, 49933
Active, not recruiting
Brest, France, 29609
Terminated
Creteil, France, 94010
Active, not recruiting
Lille, France, 59000
Active, not recruiting
Paris, France, 75014
Active, not recruiting
Paris, France, 75018
Terminated
Strasbourg, France, 67091
Active, not recruiting
Toulouse, France, 31300
Active, not recruiting
Tours, France, 37044
Germany
Active, not recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Universitätsklinikum Heidelberg Withdrawn
Heidelberg, Baden-Württemberg, Germany, 69115
Active, not recruiting
Konstanz, Baden-Württemberg, Germany, 78464
Active, not recruiting
Lahr, Baden-Württemberg, Germany, 77033
Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Active, not recruiting
Bad Neustadt, Bayern, Germany, 97616
Recruiting
Erlangen, Bayern, Germany, 91054
Recruiting
München, Bayern, Germany, 80636
Active, not recruiting
München, Bayern, Germany, 80636
Active, not recruiting
München, Bayern, Germany, 81925
Active, not recruiting
Regensburg, Bayern, Germany, 93042
Terminated
Würzburg, Bayern, Germany, 97080
Recruiting
Bad Nauheim, Hessen, Germany, 61231
Active, not recruiting
Frankfurt, Hessen, Germany, 60389
Recruiting
Fulda, Hessen, Germany, 36043
Terminated
Marburg, Hessen, Germany, 35043
Active, not recruiting
Rotenburg A.d. Fulda, Hessen, Germany, 36199
Active, not recruiting
Hannover, Niedersachsen, Germany, 30625
Completed
Aachen, Nordrhein-Westfalen, Germany, 52074
Active, not recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Active, not recruiting
Dortmund, Nordrhein-Westfalen, Germany, 44137
Active, not recruiting
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Recruiting
Krefeld, Nordrhein-Westfalen, Germany, 47805
Recruiting
Köln, Nordrhein-Westfalen, Germany, 50924
Active, not recruiting
Neuss, Nordrhein-Westfalen, Germany, 41464
Active, not recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Active, not recruiting
Homburg, Saarland, Germany, 66421
SHG-Kliniken Völklingen Withdrawn
Völklingen, Saarland, Germany, 66333
Active, not recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Recruiting
Leipzig, Sachsen, Germany, 04289
Active, not recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Active, not recruiting
Bad Berka, Thüringen, Germany, 99437
Recruiting
Bad Segeberg, Germany, 23795
Recruiting
Berlin, Germany, 10117
Recruiting
Berlin, Germany, 12200
Recruiting
Berlin, Germany, 13353
Active, not recruiting
Bremen, Germany, 28277
Terminated
Hamburg, Germany, 20099
Active, not recruiting
Hamburg, Germany, 20246
Italy
Active, not recruiting
Bergamo, Lombardia, Italy, 24127
Active, not recruiting
Milano, Lombardia, Italy, 20089
Active, not recruiting
Milano, Lombardia, Italy, 20132
Active, not recruiting
Milano, Lombardia, Italy, 20162
Terminated
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Catania, Sicilia, Italy, 95124
Active, not recruiting
Pisa, Toscana, Italy, 56124
Active, not recruiting
Padova, Veneto, Italy, 35128
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of, 110-744
Not yet recruiting
Seoul, Korea, Republic of, 120-752
Not yet recruiting
Seoul, Korea, Republic of, 135-710
Not yet recruiting
Seoul, Korea, Republic of, 137-701
Netherlands
Terminated
Amsterdam, Netherlands, 1091 AC
Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Active, not recruiting
Breda, Netherlands, 4818 CK
Terminated
Eindhoven, Netherlands, 5623 EJ
Recruiting
Rotterdam, Netherlands, 3015 CE
Norway
Active, not recruiting
Bergen, Norway, N-5021
Active, not recruiting
Oslo, Norway, 0424
Active, not recruiting
Tromsø, Norway, 9038
Poland
Active, not recruiting
Bielsko-Biala, Poland, 43-316
Active, not recruiting
Warszawa, Poland, 02-097
Active, not recruiting
Warszawa, Poland, 04-628
Spain
Active, not recruiting
Oviedo, Asturias, Spain, 33011
Active, not recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Active, not recruiting
Barcelona, Spain, 08036
Active, not recruiting
Madrid, Spain, 28046
Active, not recruiting
Málaga, Spain, 29010
Sweden
Terminated
Stockholm, Sweden, 171 76
Active, not recruiting
Uppsala, Sweden, 751 85
Switzerland
Recruiting
Basel, Basel-Stadt, Switzerland, 4056
Active, not recruiting
Lugano, Ticino, Switzerland, 6900
Recruiting
Bern, Switzerland, 3010
Active, not recruiting
Luzern, Switzerland, 6000
Active, not recruiting
Zürich, Switzerland, 8091
United Kingdom
Active, not recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Active, not recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Active, not recruiting
Blackpool, Lancashire, United Kingdom, FY3 8NR
Active, not recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Active, not recruiting
Belfast, North Ireland, United Kingdom, BT12 6BA
Terminated
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Active, not recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Active, not recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Terminated
Birmingham, United Kingdom, B15 2TH
Active, not recruiting
Edinburgh, United Kingdom, EH16 4SA
Active, not recruiting
London, United Kingdom, SE1 7EH
Active, not recruiting
London, United Kingdom, SE5 9RS
Active, not recruiting
Oxford, United Kingdom, OX9 3DU
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

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 Submitted: September 5, 2015
First Posted: September 22, 2015
Last Update Posted: November 21, 2017
Last Verified: November 2017

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