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TerminatedNCT02556203GALILEOUpdated Jan 13, 2020Results posted

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

A Phase 3 interventional study of Rivaroxaban (Xarelto, BAY59-7939) and Acetylsalicylic Acid (ASA) in Transcatheter Aortic Valve Replacement, sponsored by Bayer. Terminated at 140 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Bayer · Phase 3, Interventional, and Prevention

Why this study was terminated
Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator
Phase
Phase 3
Study type
Interventional
Enrollment
1,653
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Transcatheter Aortic Valve Replacement

Keywords

  • TAVR
  • TAVI
  • Transfemoral aortic valve implantation
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,653 participants (actual)

Study arms

  • 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) · Drug: Acetylsalicylic Acid (ASA)

  • 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) · Drug: Clopidogrel · Drug: Vitamin K antagonist (VKA)

Interventions

  • DrugRivaroxaban (Xarelto, BAY59-7939)

    10mg OD (once-daily)

  • DrugAcetylsalicylic Acid (ASA)

    75-100mg OD

  • DrugClopidogrel

    75mg OD

  • DrugRivaroxaban (Xarelto, BAY59-7939)

    In case of NOAF, 20/15 mg OD (once-daily)

  • DrugVitamin K antagonist (VKA)

    In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, on average 14 months

  2. 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.

    Time frame: Through study completion, on average 16 months

  3. 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.

    Time frame: Through study completion, on average 16 months

Secondary outcomes

  1. Number of Participants With Net-clinical Benefit

    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).

    Time frame: Through study completion, on average 16 months

  2. Number of Participants With Cardiovascular Death or Thromboembolic Event

    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).

    Time frame: Through study completion, on average 16 months

  3. Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds

    Composite of TIMI major and minor bleedings

    Time frame: Through study completion, on average 16 months

  4. Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds

    ISTH major bleeds

    Time frame: Through study completion, on average 16 months

  5. Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds

    Composite of BARC 2,3 or 5 bleedings

    Time frame: Through study completion, on average 16 months

07

Results

Posted Jan 13, 2020

Participant flow

Study was conducted at 136 centers world-wide between 16 Dec 2015 (first patient's first visit) and 27 Nov 2018 (last patient's last visit).

Participant flow — Overall Study
MilestoneRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Started826818
Received treatment801807
Completed799792
Not completed2726
Withdrew: Withdrawal by subject2121
Withdrew: Lost to follow-up55
Withdrew: Adverse event10

Outcome measures

PrimaryNumber 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.

Time frame:
Through study completion, on average 14 months
Reported as:
Count of participants · Participants
Number of Participants With Death or First Thromboembolic Event (DTE)
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Death or First Thromboembolic Event (DTE)6863
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Hazard ratio (hr): 1.2089302
PrimaryNumber 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.

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With Death or First Thromboembolic Event (DTE)
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Death or First Thromboembolic Event (DTE)10578
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.04223 · Hazard ratio (hr): 1.35 · 95% CI 1.01 to 1.81
PrimaryNumber 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.

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With Primary Bleeding Event (PBE)
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Primary Bleeding Event (PBE)4631
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.07745 · Hazard ratio (hr): 1.50 · 95% CI 0.95 to 2.37Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.
SecondaryNumber of Participants With Net-clinical Benefit

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).

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With Net-clinical Benefit
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Net-clinical Benefit137100
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.01156 · Hazard ratio (hr): 1.39 · 95% CI 1.08 to 1.80Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.
SecondaryNumber of Participants With Cardiovascular Death or Thromboembolic Event

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).

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With Cardiovascular Death or Thromboembolic Event
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Cardiovascular Death or Thromboembolic Event8368
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.21595 · Hazard ratio (hr): 1.22 · 95% CI 0.89 to 1.69Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.
SecondaryNumber of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds

Composite of TIMI major and minor bleedings

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds4224
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.02216 · Hazard ratio (hr): 1.78 · 95% CI 1.08 to 2.94Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.
SecondaryNumber of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds

ISTH major bleeds

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds4930
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.02702 · Hazard ratio (hr): 1.66 · 95% CI 1.05 to 2.62Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.
SecondaryNumber of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds

Composite of BARC 2,3 or 5 bleedings

Time frame:
Through study completion, on average 16 months
Reported as:
Count of participants · Participants
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
ParticipantsRivaroxaban (Xarelto, BAY59-7939)Antiplatelet
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds14885
Statistical analysis
  • Rivaroxaban (Xarelto, BAY59-7939) vs Antiplatelet · Log Rank · p = = 0.00001 · Hazard ratio (hr): 1.84 · 95% CI 1.41 to 2.41Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.

Adverse events

Collected over Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.. Non-serious events are listed at a 0.2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rivaroxaban Arm70/801 (8.7%)296/801 (37%)359/801 (44.8%)
Antiplatelet Arm43/807 (5.3%)282/807 (34.9%)302/807 (37.4%)
Most frequent serious events
Showing 10 of 413
Most frequent serious events
EventRivaroxaban ArmAntiplatelet Arm
Atrial fibrillationCardiac disorders17/80125/807
PneumoniaInfections and infestations23/80122/807
SyncopeNervous system disorders19/80123/807
Acute kidney injuryRenal and urinary disorders10/80117/807
Cardiac failureCardiac disorders16/80116/807
Atrioventricular block completeCardiac disorders12/80115/807
FallInjury, poisoning and procedural complications12/8015/807
OsteoarthritisMusculoskeletal and connective tissue disorders3/80110/807
DizzinessNervous system disorders9/8014/807
Cardiac failure congestiveCardiac disorders8/8013/807
Most frequent other events
Showing 10 of 177
Most frequent other events
EventRivaroxaban ArmAntiplatelet Arm
Atrial fibrillationCardiac disorders43/80144/807
DizzinessNervous system disorders32/80116/807
Urinary tract infectionInfections and infestations30/80119/807
HypertensionVascular disorders26/80128/807
Oedema peripheralGeneral disorders16/80120/807
FallInjury, poisoning and procedural complications18/80116/807
VertigoEar and labyrinth disorders17/8018/807
DyspnoeaRespiratory, thoracic and mediastinal disorders17/8016/807
SyncopeNervous system disorders10/80115/807
Cardiac failureCardiac disorders14/80111/807

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Rivaroxaban (Xarelto, BAY59-7939)AntiplateletTotal
Mean80.38 ± 7.1280.77 ± 5.9980.57 ± 6.58
Sex: Female, Male
Sex: Female, Male(Participants)Rivaroxaban (Xarelto, BAY59-7939)AntiplateletTotal
Female400413813
Male426405831
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Rivaroxaban (Xarelto, BAY59-7939)AntiplateletTotal
Hispanic or Latino261743
Not Hispanic or Latino6776941371
Unknown or Not Reported123107230
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Rivaroxaban (Xarelto, BAY59-7939)AntiplateletTotal
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander022
Black or African American9716
White6926931385
More than one race000
Unknown or Not Reported123115238
08

Study locations

140 sites
  • Los Angeles, California 90048-0750, United States
  • Washington, District of Columbia 20010, United States
  • Clearwater, Florida 33756, United States
  • Jacksonville, Florida 32209, United States
  • Miami, Florida 33136, United States
  • Atlanta, Georgia 30322, United States
  • Chicago, Illinois 60611, United States
  • Evanston, Illinois 60201, United States
  • West Des Moines, Iowa 50266, United States
  • Baltimore, Maryland 21201, United States
  • Boston, Massachusetts 02215, United States
  • Detroit, Michigan 48202, United States
  • Minneapolis, Minnesota 55407, United States
  • Kansas City, Missouri 64111, United States
  • Morristown, New Jersey 07962, United States
  • Manhasset, New York 11030-3876, United States
  • New York, New York 10029, United States
  • Roslyn, New York 11576, United States
  • Winston-Salem, North Carolina 27157-1082, United States
  • Cincinnati, Ohio 45219, United States
  • Cleveland, Ohio 44195, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Wilkes-Barre, Pennsylvania 18711-3752, United States
  • Houston, Texas 77030-1501, United States
  • Houston, Texas 77030, United States
  • Plano, Texas 75093, United States
  • Temple, Texas 76508, United States
  • Burlington, Vermont 05401, United States
  • Charlottesville, Virginia 22908, United States
  • Falls Church, Virginia 22042-3300, United States
  • Tacoma, Washington 98405, United States
  • Linz, Oberösterreich 4020, Austria
  • Wels, Oberösterreich 4600, Austria
  • Graz, Steiermark 8036, Austria
  • Salzburg, 5020, Austria
  • Wien, 1090, Austria
  • Wien, 1130, Austria
  • Wien, 1160, Austria
  • Genk, 3600, Belgium
  • Hasselt, 3500, Belgium
  • Liege, 4000, Belgium
  • Edmonton, Alberta T6G 2B7, Canada
  • Vancouver, British Columbia V6A 1Y6, Canada
  • Victoria, British Columbia V8R 4R2, Canada
  • Winnipeg, Manitoba R2H 2A6, Canada
  • Halifax, Nova Scotia B3H 3A7, Canada
  • Newmarket, Ontario L3Y 2P7, Canada
  • Toronto, Ontario M4N 3M5, Canada
  • Toronto, Ontario M5G 2C4, Canada
  • Montreal, Quebec H1T 1C8, Canada
  • Brno, 656 91, Czechia
  • Praha 10, 10034, Czechia
  • Praha 4, 140 21, Czechia
  • Aarhus N, 8200, Denmark
  • Copenhagen, DK-2100, Denmark
  • Odense C, DK-5000, Denmark
  • Angers, 49100, France
  • Brest, 29609, France
  • Chambray-lès-Tours, 37170, France
  • Lille, 59000, France
  • Paris, 75014, France
  • Paris, 75018, France
  • Toulouse, 31300, France
  • Freiburg, Baden-Württemberg 79106, Germany
  • Konstanz, Baden-Württemberg 78464, Germany
  • Lahr, Baden-Württemberg 77033, Germany
  • Tübingen, Baden-Württemberg 72076, Germany
  • Ulm, Baden-Württemberg 89081, Germany
  • Bad Neustadt, Bayern 97616, Germany
  • Erlangen, Bayern 91054, Germany
  • München, Bayern 80331, Germany
  • München, Bayern 80636, Germany
  • München, Bayern 81925, Germany
  • Regensburg, Bayern 93042, Germany
  • Bad Nauheim, Hessen 61231, Germany
  • Frankfurt, Hessen 60389, Germany
  • Fulda, Hessen 36043, Germany
  • Rotenburg A.d. Fulda, Hessen 36199, Germany
  • Hannover, Niedersachsen 30625, Germany
  • Aachen, Nordrhein-Westfalen 52074, Germany
  • Bonn, Nordrhein-Westfalen 53105, Germany
  • Dortmund, Nordrhein-Westfalen 44137, Germany
  • Düsseldorf, Nordrhein-Westfalen 40225, Germany
  • Krefeld, Nordrhein-Westfalen 47805, Germany
  • Köln, Nordrhein-Westfalen 50924, Germany
  • Neuss, Nordrhein-Westfalen 41464, Germany
  • Mainz, Rheinland-Pfalz 55131, Germany
  • Homburg, Saarland 66424, Germany
  • Magdeburg, Sachsen-Anhalt 39120, Germany
  • Leipzig, Sachsen 04289, Germany
  • Bad Segeberg, Schleswig-Holstein 23795, Germany
  • Kiel, Schleswig-Holstein 24105, Germany
  • Bad Berka, Thüringen 99437, Germany
  • Berlin, 10117, Germany
  • Berlin, 12200, Germany
  • Berlin, 13353, Germany
  • Bremen, 28277, Germany
  • Hamburg, 20246, Germany
  • Bergamo, Lombardia 24127, Italy
  • Milano, Lombardia 20089, Italy

Showing the first 100 of 140 sites across 17 countries.

09

References and documents

Publications

  • 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. PubMed 36040717 ↗
  • 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. PubMed 31733180 ↗
  • 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. PubMed 29536857 ↗
  • 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. PubMed 27892890 ↗

Study documents

  • Study protocol · Aug 17, 2016
  • Statistical analysis plan · Dec 15, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02556203
Lead sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Sep 22, 2015
Start date
Dec 16, 2015
Primary completion
Nov 27, 2018
Completion
Nov 27, 2018
Results posted
Jan 13, 2020
Last update
Jan 13, 2020

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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