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

December 23, 2019 updated by: Bayer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1653

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1130
      • Wien, Austria, 1160
      • Wien, Austria, 1090
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
      • Wels, Oberösterreich, Austria, 4600
    • Steiermark
      • Graz, Steiermark, Austria, 8036
  • Belgium
      • Genk, Belgium, 3600
      • Hasselt, Belgium, 3500
      • Liege, Belgium, 4000
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6A 1Y6
      • Victoria, British Columbia, Canada, V8R 4R2
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P7
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2C4
    • 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, 49100
      • Brest, France, 29609
      • Chambray-lès-Tours, France, 37170
      • Lille, France, 59000
      • Paris, France, 75018
      • Paris, France, 75014
      • Toulouse, France, 31300
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 12200
      • Berlin, Germany, 13353
      • Bremen, Germany, 28277
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • 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
    • Bayern
      • Bad Neustadt, Bayern, Germany, 97616
      • Erlangen, Bayern, Germany, 91054
      • München, Bayern, Germany, 81925
      • München, Bayern, Germany, 80331
      • München, Bayern, Germany, 80636
      • Regensburg, Bayern, Germany, 93042
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
      • Frankfurt, Hessen, Germany, 60389
      • Fulda, Hessen, Germany, 36043
      • Rotenburg A.d. Fulda, Hessen, Germany, 36199
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66424
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
      • Kiel, Schleswig-Holstein, Germany, 24105
    • Thüringen
      • Bad Berka, Thüringen, Germany, 99437
  • Italy
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20089
      • Milano, Lombardia, Italy, 20162
    • Sicilia
      • Catania, Sicilia, Italy, 95124
    • Toscana
      • Pisa, Toscana, Italy, 56124
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 06591
  • 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
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28046
      • Málaga, Spain, 29010
    • Asturias
      • Oviedo, Asturias, Spain, 33011
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Sweden
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Bern, Switzerland, 3010
      • Luzern, Switzerland, 6000
      • Zürich, Switzerland, 8091
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, SE1 7EH
      • Oxford, United Kingdom, OX9 3DU
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
    • North Ireland
      • Belfast, North Ireland, United Kingdom, BT12 6BA
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
  • United States
    • California
      • Los Angeles, California, United States, 90048-0750
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Clearwater, Florida, United States, 33756
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Evanston, Illinois, United States, 60201
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
    • Missouri
      • Kansas City, Missouri, United States, 64111
    • New Jersey
      • Morristown, New Jersey, United States, 07962
    • New York
      • Manhasset, New York, United States, 11030-3876
      • New York, New York, United States, 10029
      • Roslyn, New York, United States, 11576
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Wilkes-Barre, Pennsylvania, United States, 18711-3752
    • Texas
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030-1501
      • Plano, Texas, United States, 75093
      • Temple, Texas, United States, 76508
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Falls Church, Virginia, United States, 22042-3300
    • Washington
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
10mg OD (once-daily)
Drug: Acetylsalicylic Acid (ASA)
75-100mg OD
Drug: Rivaroxaban (Xarelto, BAY59-7939)
In case of NOAF, 20/15 mg OD (once-daily)
ACTIVE_COMPARATOR: 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.
Drug: Acetylsalicylic Acid (ASA)
75-100mg OD
Drug: Clopidogrel
75mg OD
Drug: Vitamin K antagonist (VKA)
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Death or First Thromboembolic Event (DTE)
Time Frame: Through study completion, on average 14 months
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)
Time Frame: Through study completion, on average 16 months
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)
Time Frame: Through study completion, on average 16 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Net-clinical Benefit
Time Frame: Through study completion, on average 16 months
The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).
Through study completion, on average 16 months
Number of Participants With Cardiovascular Death or Thromboembolic Event
Time Frame: Through study completion, on average 16 months
Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
Through study completion, on average 16 months
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
Time Frame: Through study completion, on average 16 months
Composite of TIMI major and minor bleedings
Through study completion, on average 16 months
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
Time Frame: Through study completion, on average 16 months
ISTH 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
Time Frame: Through study completion, on average 16 months
Composite of BARC 2,3 or 5 bleedings
Through study completion, on average 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2015

Primary Completion (ACTUAL)

November 27, 2018

Study Completion (ACTUAL)

November 27, 2018

Study Registration Dates

First Submitted

September 5, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (ESTIMATE)

September 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17938
  • 2015-001975-30 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Transcatheter Aortic Valve Replacement

Clinical Trials on Rivaroxaban (Xarelto, BAY59-7939)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe