AzTrials
AzTrials

Transcatheter Aortic Valve ReplacementPhase 3GALILEONCT02556203

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 study testing Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA) and Clopidogrel in people with Transcatheter Aortic Valve Replacement, run by Bayer at 140 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transcatheter Aortic Valve Replacement
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA) and Clopidogrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,653 participants
Where
140 sitesin 17 countries
Study dates
16 Dec 2015to 27 Nov 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

140 sites in 17 countries.

140 sites in 17 countries

Germany35 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Bad Berka, Thuringia, 99437

  • Study site

    Bad Nauheim, Hesse, 61231

  • Study site

    Bad Neustadt an der Saale, Bavaria, 97616

  • Study site

    Bad Segeberg, Schleswig-Holstein, 23795

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 12200

  • Study site

    Berlin, 13353

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Bremen, 28277

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Dortmund, North Rhine-Westphalia, 44137

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Fulda, Hesse, 36043

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66424

  • Study site

    Kiel, Schleswig-Holstein, 24105

  • Study site

    Konstanz, Baden-Wurttemberg, 78464

  • Study site

    Krefeld, North Rhine-Westphalia, 47805

  • Study site

    Lahr, Baden-Wurttemberg, 77033

  • Study site

    Leipzig, Saxony, 04289

  • Study site

    Magdeburg, Saxony-Anhalt, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 80331

  • Study site

    München, Bavaria, 80636

  • Study site

    München, Bavaria, 81925

  • Study site

    Neuss, North Rhine-Westphalia, 41464

  • Study site

    Regensburg, Bavaria, 93042

  • Study site

    Rotenburg A.d. Fulda, Hesse, 36199

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

United States31 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Falls Church, Virginia, 22042-3300

  • Study site

    Houston, Texas, 77030-1501

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Los Angeles, California, 90048-0750

  • Study site

    Manhasset, New York, 11030-3876

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    New York, New York, 10029

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Plano, Texas, 75093

  • Study site

    Roslyn, New York, 11576

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Temple, Texas, 76508

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    Wilkes-Barre, Pennsylvania, 18711-3752

  • Study site

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

United Kingdom11 sites

  • Study site

    Belfast, North Ireland, BT12 6BA

  • Study site

    Blackpool, Lancashire, FY3 8NR

  • Study site

    Brighton, East Sussex, BN2 5BE

  • Study site

    Edinburgh, EH16 4SA

  • Study site

    Leeds, West Yorkshire, LS1 3EX

  • Study site

    Leicester, Leicestershire, LE3 9QP

  • Study site

    London, SE1 7EH

  • Study site

    London, SE5 9RS

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Study site

    Oxford, OX9 3DU

  • Study site

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Canada9 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Halifax, Nova Scotia, B3H 3A7

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Newmarket, Ontario, L3Y 2P7

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2C4

  • Study site

    Vancouver, British Columbia, V6A 1Y6

  • Study site

    Victoria, British Columbia, V8R 4R2

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Austria7 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1160

  • Study site

    Wels, Upper Austria, 4600

Other trials in Austria

France7 sites

  • Study site

    Angers, 49100

  • Study site

    Brest, 29609

  • Study site

    Chambray-lès-Tours, 37170

  • Study site

    Lille, 59000

  • Study site

    Paris, 75014

  • Study site

    Paris, 75018

  • Study site

    Toulouse, 31300

Other trials in France

Italy7 sites

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Catania, Sicily, 95124

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Padova, Veneto, 35128

  • Study site

    Pisa, Tuscany, 56124

Other trials in Italy

Spain5 sites

  • Study site

    Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28046

  • Study site

    Málaga, 29010

  • Study site

    Oviedo, Principality of Asturias, 33011

Other trials in Spain

Switzerland5 sites

  • Study site

    Basel, Canton of Basel-City, 4056

  • Study site

    Bern, 3010

  • Study site

    Lucerne, 6000

  • Study site

    Lugano, Canton Ticino, 6900

  • Study site

    Zurich, 8091

Other trials in Switzerland

South Korea4 sites

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 06591

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

Other trials in South Korea

Belgium3 sites

  • Study site

    Genk, 3600

  • Study site

    Hasselt, 3500

  • Study site

    Liège, 4000

Other trials in Belgium

Czechia3 sites

  • Study site

    Brno, 656 91

  • Study site

    Prague, 10034

  • Study site

    Prague, 140 21

Other trials in Czechia

Denmark3 sites

  • Study site

    Aarhus N, 8200

  • Study site

    Copenhagen, DK-2100

  • Study site

    Odense C, DK-5000

Other trials in Denmark

Netherlands3 sites

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Breda, 4818 CK

  • Study site

    Rotterdam, 3015 CE

Other trials in Netherlands

Norway3 sites

  • Study site

    Bergen, N-5021

  • Study site

    Oslo, 0424

  • Study site

    Tromsø, 9038

Other trials in Norway

Poland3 sites

  • Study site

    Bielsko-Biala, 43-316

  • Study site

    Warsaw, 02-097

  • Study site

    Warsaw, 04-628

Other trials in Poland

Sweden1 site

  • Study site

    Uppsala, 751 85

Other trials in Sweden

About this study

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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel, Vitamin K antagonist (VKA)
Keywords
TAVR, TAVI, Transfemoral aortic valve implantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    10mg OD (once-daily)

  • Acetylsalicylic Acid (ASA)Drug

    75-100mg OD

  • ClopidogrelDrug

    75mg OD

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

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

  • Vitamin K antagonist (VKA)Drug

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

Study groups in NCT02556203
Study groupRoleWhat they receive
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.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Acetylsalicylic Acid (ASA)
AntiplateletActive 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.
Receives: Drug: Acetylsalicylic Acid (ASA); Drug: Clopidogrel; Drug: Vitamin K antagonist (VKA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Through study completion, on average 16 months

Secondary outcomes (5)

  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).

    Measured: 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).

    Measured: 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

    Measured: Through study completion, on average 16 months

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

    ISTH major bleeds

    Measured: 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

    Measured: Through study completion, on average 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study start16 Dec 2015
  3. Primary completion27 Nov 2018
  4. Study completion27 Nov 2018

Why it stopped: Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,653 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02556203
Sponsor's protocol ID
17938
Other IDs
2015-001975-30, 2015
Acronym
GALILEO
Status last verified
Dec 2019
First submitted
5 Sep 2015
Last updated
13 Jan 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

  • Wohrle 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.

    PubMed 35934563

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA) and Clopidogrel in people with Transcatheter Aortic Valve Replacement, run by Bayer at 140 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in Germany, United States, United Kingdom, Canada, Austria and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Death or First Thromboembolic Event (DTE) (time frame: Through study completion, on average 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556203, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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