Trial Condition(s):

Transcatheter Aortic Valve Replacement

Global study comparing a rivAroxaban-based antithrombotic strategy to an antipLatelet-based strategy after transcatheter aortIc vaLve rEplacement to Optimize clinical outcomes (GALILEO)

Bayer Identifier:

17938

ClinicalTrials.gov Identifier:

NCT02556203

EudraCT Number:

2015-001975-30

Terminated/Withdrawn

Trial 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 antiplatelet-based strategy, following TAVR.

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

Trial Summary

Enrollment Goal
1653
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1130

Status
Completed
 
Locations

Investigative Site

Wels, Austria, 4600

Status
Completed
 
Locations

Investigative Site

Salzburg, Austria, 5020

Status
Completed
 
Locations

Investigative Site

Linz, Austria, 4020

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 656 91

Status
Completed
 
Locations

Investigative Site

Bad Nauheim, Germany, 61231

Status
Completed
 
Locations

Investigative Site

Bad Berka, Germany, 99437

Status
Completed
 
Locations

Investigative Site

Bad Neustadt, Germany, 97616

Status
Completed
 
Locations

Investigative Site

Bad Segeberg, Germany, 23795

Status
Completed
 
Locations

Investigative Site

Erlangen, Germany, 91054

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 10117

Status
Completed
 
Locations

Investigative Site

Magdeburg, Germany, 39120

Status
Completed
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Completed
 
Locations

Investigative Site

Regensburg, Germany, 93042

Status
Completed
 
Locations

Investigative Site

Bonn, Germany, 53105

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50924

Status
Completed
 
Locations

Investigative Site

Lahr, Germany, 77033

Status
Completed
 
Locations

Investigative Site

München, Germany, 80331

Status
Completed
 
Locations

Investigative Site

Rotenburg a.d. Fulda, Germany, 36199

Status
Completed
 
Locations

Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
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Investigative Site

Berlin, Germany, 12200

Status
Completed
 
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Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
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Investigative Site

Basel, Switzerland, 4056

Status
Completed
 
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Investigative Site

Luzern, Switzerland, 6000

Status
Completed
 
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Investigative Site

Zürich, Switzerland, 8091

Status
Completed
 
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Investigative Site

Madrid, Spain, 28046

Status
Completed
 
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Investigative Site

Oviedo, Spain, 33011

Status
Completed
 
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Investigative Site

Málaga, Spain, 29010

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Investigative Site

Berlin, Germany, 13353

Status
Completed
 
Locations

Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
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Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Neuss, Germany, 41464

Status
Completed
 
Locations

Investigative Site

Fulda, Germany, 36043

Status
Recruiting
 
Locations

Investigative Site

BREST, France, 29609

Status
Completed
 
Locations

Investigative Site

Praha 10, Czech Republic, 10034

Status
Completed
 
Locations

Investigative Site

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Investigative Site

Bielsko-Biala, Poland, 43-316

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 04-628

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 02-097

Status
Completed
 
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Investigative Site

Brighton, United Kingdom, BN2 5BE

Status
Completed
 
Locations

Investigative Site

Leeds, United Kingdom, LS1 3EX

Status
Completed
 
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Investigative Site

Leicester, United Kingdom, LE3 9QP

Status
Completed
 
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Investigative Site

London, United Kingdom, SE1 7EH

Status
Completed
 
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Investigative Site

Belfast, United Kingdom, BT12 6BA

Status
Completed
 
Locations

Investigative Site

Edinburgh, United Kingdom, EH16 4SA

Status
Completed
 
Locations

Investigative Site

Blackpool, United Kingdom, FY3 8NR

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1160

Status
Completed
 
Locations

Investigative Site

Krefeld, Germany, 47805

Status
Recruiting
 
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Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
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Investigative Site

Leipzig, Germany, 04289

Status
Completed
 
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 
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Investigative Site

New York, United States, 10029

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95124

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20162

Status
Completed
 
Locations

Investigative Site

Charlottesville, United States, 22908

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
Locations

Investigative Site

Plano, United States, 75093

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60611

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Completed
 
Locations

Investigative Site

Burlington, United States, 05401

Status
Completed
 
Locations

Investigative Site

Kansas City, United States, 64111

Status
Completed
 
Locations

Investigative Site

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Investigative Site

HASSELT, Belgium, 3500

Status
Completed
 
Locations

Investigative Site

GENK, Belgium, 3600

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24127

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Pisa, Italy, 56124

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27157-1082

Status
Completed
 
Locations

Investigative Site

Evanston, United States, 60201

Status
Completed
 
Locations

Investigative Site

Roslyn, United States, 11576

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030-1501

Status
Completed
 
Locations

Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Completed
 
Locations

Investigative Site

Oxford, United Kingdom, OX9 3DU

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Investigative Site

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Investigative Site

BREDA, Netherlands, 4818 CK

Status
Completed
 
Locations

Investigative Site

Copenhagen, Denmark, DK-2100

Status
Completed
 
Locations

Investigative Site

Odense C, Denmark, DK-5000

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0424

Status
Completed
 
Locations

Investigative Site

Tromsø, Norway, 9038

Status
Completed
 
Locations

Investigative Site

Bergen, Norway, N-5021

Status
Completed
 
Locations

Investigative Site

TOULOUSE, France, 31300

Status
Completed
 
Locations

Investigative Site

Chambray-lès-Tours, France, 37170

Status
Completed
 
Locations

Investigative Site

Angers, France, 49100

Status
Completed
 
Locations

Investigative Site

LILLE, France, 59000

Status
Completed
 
Locations

Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Investigative Site

Newmarket, Canada, L3Y 2P7

Status
Completed
 
Locations

Investigative Site

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M5G 2C4

Status
Completed
 
Locations

Investigative Site

Vancouver, Canada, V6A 1Y6

Status
Completed
 
Locations

Investigative Site

Victoria, Canada, V8R 4R2

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 06351

Status
Not yet recruiting
 
Locations

Investigative Site

Seoul, South Korea, 110-744

Status
Not yet recruiting
 
Locations

Investigative Site

Seoul, South Korea, 06591

Status
Not yet recruiting
 
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Not yet recruiting
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20010

Status
Completed
 
Locations

Investigative Site

Cincinnati, United States, 45219

Status
Completed
 
Locations

Investigative Site

Detroit, United States, 48202

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33136

Status
Completed
 
Locations

Investigative Site

Clearwater, United States, 33756

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30322

Status
Completed
 
Locations

Investigative Site

Wilkes-Barre, United States, 18711-3752

Status
Completed
 
Locations

Investigative Site

Manhasset, United States, 11030-3876

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90048-0750

Status
Completed
 
Locations

Investigative Site

Minneapolis, United States, 55407

Status
Completed
 
Locations

Investigative Site

München, Germany, 81925

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60389

Status
Completed
 
Locations

Investigative Site

Dortmund, Germany, 44137

Status
Completed
 
Locations

Investigative Site

Halifax, Canada, B3H 3A7

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Morristown, United States, 07962

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H1T 1C8

Status
Completed
 
Locations

Investigative Site

Aachen, Germany, 52074

Status
Completed
 
Locations

Investigative Site

Ulm, Germany, 89081

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02215

Status
Completed
 
Locations

Investigative Site

Winnipeg, Canada, R2H 2A6

Status
Completed
 
Locations

Investigative Site

Jacksonville, United States, 32209

Status
Completed
 
Locations

Investigative Site

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Investigative Site

Homburg, Germany, 66424

Status
Completed
 
Locations

Investigative Site

Konstanz, Germany, 78464

Status
Completed
 
Locations

Investigative Site

Tacoma, United States, 98405

Status
Completed
 
Locations

Investigative Site

Temple, United States, 76508

Status
Completed
 
Locations

Investigative Site

West Des Moines, United States, 50266

Status
Completed
 
Locations

Investigative Site

Falls Church, United States, 22042-3300

Status
Completed
 
Locations

Investigative Site

München, Germany, 80636

Status
Completed
 
Locations

Investigative Site

Lugano, Switzerland, 6900

Status
Completed
 
Locations

Investigative Site

Bremen, Germany, 28277

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75014

Status
Terminated
 
Locations

Investigative Site

Paris, France, 75018

Status
Completed
 

Trial Design