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

This study is currently recruiting participants.
Verified October 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02556203
First Posted: September 22, 2015
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
September 5, 2015
September 22, 2015
October 23, 2017
December 16, 2015
November 30, 2018   (Final data collection date for primary outcome measure)
  • Death or first adjudicated thromboembolic event (DTE) defined as composite of all-cause death and adjudicated any stroke, MI, symptomatic valve thrombosis, PE, DVT, or non-CNS SE [ Time Frame: Up to 25 months ]
    MI: Myocardial infarction, PE: Pulmonary embolism, DVT: Deep vein thrombosis, non-CNS SE: Non-central nervous system systemic embolism
  • Primary bleeding event defined as the composite of adjudicated life-threatening, disabling or major bleeding, classified according to the VARC definitions following the BARC classification [ Time Frame: Up to 25 months ]
    VARC:Valve academic research consortium, BARC: Bleeding academic research consortium
Same as current
Complete list of historical versions of study NCT02556203 on ClinicalTrials.gov Archive Site
  • Composite of cardiovascular death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis or non-CNS systemic embolism [ Time Frame: Up to 25 months ]
  • Net-clinical-benefit defined as the composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism, life threatening, disabling and major bleeds [ Time Frame: Up to 25 months ]
  • Bleeding complications defined as any of the following: composite of TIMI major or minor bleeds, ISTH major bleeding, composite of BARC 2, 3, or 5 bleeding [ Time Frame: Up to 25 months ]
    TIMI: Thrombolysis in Myocardial Infarction, ISTH: International Society on Thrombosis and Haemostasis
Same as current
Not Provided
Not Provided
 
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
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 antiplateletbased strategy, following TAVR.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Transcatheter Aortic Valve Replacement
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    10 mg OD (once-daily)
  • Drug: Acetylsalicylic acid
    75 - 100 mg OD (for first 90 days only in arm 1)
  • Drug: Clopidogrel
    75 mg OD for first 90 days
  • Experimental: Rivaroxaban + ASA
    Rivaroxaban + ASA (Acetylsalicylic acid) followed by rivaroxaban alone
    Interventions:
    • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    • Drug: Acetylsalicylic acid
  • Active Comparator: ASA + Clopidogrel
    ASA + Clopidogrel followed by ASA alone
    Interventions:
    • Drug: Acetylsalicylic acid
    • Drug: Clopidogrel
Windecker S, Tijssen J, Giustino G, Guimarães 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1520
November 30, 2018
November 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937
Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Czech Republic
 
NCT02556203
17938
2015-001975-30 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
Bayer
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP