NCT02556203 (GALILEO) is a Phase 3 clinical trial of Rivaroxaban (Xarelto, BAY59-7939) in Transcatheter Aortic Valve Replacement, sponsored by Bayer.

Who is sponsoring NCT02556203?

NCT02556203 is sponsored by Bayer.

What drugs are being tested in NCT02556203?

Interventions in NCT02556203: Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel, Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA).

What condition does NCT02556203 study?

NCT02556203 studies Transcatheter Aortic Valve Replacement.

Is NCT02556203 still recruiting?

NCT02556203 is currently terminated. Last updated 13 January 2020.

Are results published for NCT02556203?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-13 · How we verify

NCT02556203: GALILEO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Results posted Last updated 13 January 2020

What this trial tests

Phase 3 trial testing Rivaroxaban (Xarelto, BAY59-7939) in Transcatheter Aortic Valve Replacement in 1,653 participants. Terminated before completion.

Timeline

16 December 2015

Primary endpoint
27 November 2018

27 November 2018

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,653
Start date	16 December 2015
Primary completion	27 November 2018
Estimated completion	27 November 2018
Sites	140 locations across Czechia, Netherlands, Poland, Belgium, Austria, United Kingdom, South Korea, Canada

Drugs / interventions tested

Rivaroxaban (Xarelto, BAY59-7939) — full drug profile →
Acetylsalicylic Acid (ASA) — full drug profile →
Clopidogrel (clopidogrel) — full drug profile →
Rivaroxaban (Xarelto, BAY59-7939) — full drug profile →
Vitamin K antagonist (VKA) (vitamin-k-antagonist-vka) — full drug profile →

Conditions studied

Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Transcatheter Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.
Dangas GD, Tijssen JGP, Wöhrle J, Søndergaard L, et al · · 2020 · cited 366× · PMID 31733180 · DOI 10.1056/nejmoa1911425
Clinical Valve Thrombosis and Subclinical Leaflet Thrombosis Following Transcatheter Aortic Valve Replacement: Is There a Need for a Patient-Tailored Antithrombotic Therapy?
Rosseel L, De Backer O, Søndergaard L. · · 2019 · cited 51× · PMID 31058168 · DOI 10.3389/fcvm.2019.00044
Prosthetic Aortic Valves: Challenges and Solutions.
Musumeci L, Jacques N, Hego A, Nchimi A, et al · · 2018 · cited 21× · PMID 29868612 · DOI 10.3389/fcvm.2018.00046
Spotlight on the SAPIEN 3 transcatheter heart valve.
Rheude T, Blumenstein J, Möllmann H, Husser O. · · 2018 · cited 16× · PMID 30319292 · DOI 10.2147/mder.s143897
Transcatheter aortic valve replacement in intermediate and low risk patients-clinical evidence.
Arora S, Vavalle JP. · · 2017 · cited 15× · PMID 29062744 · DOI 10.21037/acs.2017.07.01
Clinical valve thrombosis and subclinical leaflet thrombosis in transcatheter aortic heart valves: clinical manifestations, diagnosis, and treatment.
Rosseel L, De Backer O, Søndergaard L. · · 2018 · cited 11× · PMID 35692701 · DOI 10.1093/pcmedi/pby016
Impact of leaflet thrombosis on hemodynamics and clinical outcomes after bioprosthetic aortic valve replacement: A meta-analysis.
Tian Z, Li T, Ma S. · · 2020 · cited 10× · PMID 31957895 · DOI 10.1002/clc.23331
A Glimpse into the Future: In 2020, Which Patients will Undergo TAVI or SAVR?
O'Sullivan CJ, Wenaweser P. · · 2017 · cited 9× · PMID 29588730 · DOI 10.15420/icr.2016:24:2

Verify or expand the search:

Other trials of Rivaroxaban (Xarelto, BAY59-7939)

Trials testing the same drug.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT06193863 — An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Hea · active not recruiting
NCT05461807 — An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to · completed
NCT05150938 — A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE) · completed
NCT04923139 — A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Datab · completed

Other recruiting trials for Transcatheter Aortic Valve Replacement

Currently open trials in the same condition.

NCT06559332 — Coronary Artery Disease Assessment Strategies in TAVI Patients · NA · recruiting
NCT06896227 — TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics · NA · recruiting
NCT06420830 — Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. · recruiting
NCT05758701 — CT TAVR Abdomen Study · Phase 4 · recruiting
NCT06000943 — Ischemic And Bleeding Risk Assessment After TAVR · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02556203 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 13 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02556203.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing