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Trial record 11 of 53 for:    galileo
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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556203
Recruitment Status : Terminated (Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator)
First Posted : September 22, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Transcatheter Aortic Valve Replacement Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Acetylsalicylic Acid (ASA) Drug: Clopidogrel Drug: Vitamin K antagonist (VKA) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
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)
10mg OD (once-daily)

Drug: Acetylsalicylic Acid (ASA)
75-100mg OD

Drug: Rivaroxaban (Xarelto, BAY59-7939)
In case of NOAF, 20/15 mg OD (once-daily)
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)
75-100mg OD

Drug: Clopidogrel
75mg OD

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Death or First Thromboembolic Event (DTE) [ Time Frame: Through study completion, on average 14 months ]
    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.

  2. Number of Participants With Death or First Thromboembolic Event (DTE) [ Time Frame: Through study completion, on average 16 months ]
    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.

  3. Number of Participants With Primary Bleeding Event (PBE) [ Time Frame: Through study completion, on average 16 months ]
    PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.


Secondary Outcome Measures :
  1. Number of Participants With Net-clinical Benefit [ Time Frame: Through study completion, on average 16 months ]
    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).

  2. Number of Participants With Cardiovascular Death or Thromboembolic Event [ Time Frame: Through study completion, on average 16 months ]
    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).

  3. Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds [ Time Frame: Through study completion, on average 16 months ]
    Composite of TIMI major and minor bleedings

  4. Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds [ Time Frame: Through study completion, on average 16 months ]
    ISTH major bleeds

  5. Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds [ Time Frame: Through study completion, on average 16 months ]
    Composite of BARC 2,3 or 5 bleedings


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556203


Locations
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Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] August 17, 2016
Statistical Analysis Plan  [PDF] December 15, 2016

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02556203    
Other Study ID Numbers: 17938
2015-001975-30 ( EudraCT Number )
First Posted: September 22, 2015    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
TAVR
TAVI
Transfemoral aortic valve implantation
Additional relevant MeSH terms:
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Aspirin
Vitamin K
Rivaroxaban
Clopidogrel
Vitamins
Micronutrients
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
 Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors