Trial document




drksid header

  DRKS00010225

Trial Description

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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.

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Trial Acronym

GALILEO

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URL of the Trial

http://www.cardialysis.com/galileo

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Brief Summary in Lay Language

Narrowing of the aortic valve opening, called aortic stenosis, which is
treated with Transcatheter aortic valve replacement, implanted by vascular catheterization in the aortic valve. Patients with severe aortic stenosis that require Transcatheter aortic valve replacement are at risk of thrombus formation. Rivaroxaban (oralanticoagulant)
may reduce this risk, without increasing bleeding risk.

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Brief Summary in Scientific Language

The secondary efficacy objectives are to compare the effects of the
rivaroxaban-based strategy and antiplatelet-based strategy with respect to the net-clinical-benefit, defined as the composite of death or first thromboembolic events and life-threatening, disabling, or major bleeding events classified according to the VARC definitions following the BARC classification.
Whereas the secondary safety objectives are safety criteria with respect to bleeding (thrombolysis in myocardial infarction [TIMI] major or minor
bleeds, international society on thrombosis and haemostasis [ISTH] major bleeding, and BARC 2, 3, or 5 bleeds).

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Organizational Data

  •   DRKS00010225
  •   2016/03/31
  •   [---]*
  •   no
  •   Approved
  •   198/15, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   2015-001975-30 
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Health Condition or Problem studied

  •   Aortic valve replacment
  •   Z95.2 -  Presence of prosthetic heart valve
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Interventions/Observational Groups

  •   Rivaroxaban-based strategy
    • Rivaroxaban 10 mg once-daily AND Acetylsalicylic Acid (ASA) 75-100 mg once-daily
    • Rivaroxaban 10 mg once-daily
    Whether Rivaroxaban is given alone or in combination with ASA depends on the time point after the TAVI.
    If new-onset atrial fibrillation (NOAF) occurs:
    • Rivaroxaban 20 or 15 mg once-daily AND ASA 75-100 mg once-daily
    • Rivaroxaban 20 or 15 mg once-daily

    All medications are tablets and to be taken orally. Since this is an event driven study the study duration can only be given as an estimation, which will be approximately two years, but this can also be shorter like only one year.
  •   Antiplatelet-based strategy
    • Clopidogrel hydrogen sulfate (clopidogrel) 75 mg once-daily AND ASA 75-100 mg once-daily
    • ASA 75-100 mg once-daily

    If NOAF occurs:
    • Vitamin K antagonist (VKA) with a target international normalized ratio (INR) 2-3 AND ASA 75-100 mg once-daily
    • VKA (target INR 2-3)

    All medications are tablets and to be taken orally. Since this is an event driven study the study duration can only be given as an estimation, which will be approximately two years, but this can also be shorter like only one year.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   No
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Primary Outcome

The primary comparison will be to test the superiority of a rivaroxaban-based strategy to an antiplatelet-based strategy with respect to the primary efficacy endpoint. This comparison is preceded by a non-inferiority test that must be satisfied.
Further, non-inferiority of a rivaroxaban-based strategy to an antiplatelet-based strategy towards the primary safety endpoint will be tested.

Primary Efficacy Endpoint: death or first adjudicated thromboembolic event (DTE) defined as the composite of all-cause death and adjudicated any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), or non-CNS systemic embolism.
Primary Safety Endpoint: primary bleeding event (PBE) defined as the composite of adjudicated life-threatening, disabling or major bleeding, classified according to the valve academic research consortium (VARC) definitions following the bleeding academic research consortium (BARC) classification.

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Secondary Outcome

The secondary efficacy objectives are to compare the effects of the rivaroxaban-based strategy and antiplatelet-based strategy with respect to the net-clinical-benefit, defined as the composite of death or first thromboembolic events and life-threatening, disabling, or major bleeding events classified according to the VARC definitions following the BARC classification.
Whereas the secondary safety objectives are safety criteria with respect to bleeding (thrombolysis in myocardial infarction [TIMI] major or minor bleeds, international society on thrombosis and haemostasis [ISTH] major bleeding, and BARC 2, 3, or 5 bleeds).

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   Canada
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Norway
  •   Poland
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
  •   United States
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/03/17
  •   1520
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Key inclusion criteria:
• Successful TAVR of a native aortic valve stenosis
• By iliofemoral or subclavian access
• With any approved/marketed device
• Written informed consent (IC)

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Exclusion Criteria

Key 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 indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation)
• 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.
Screening, IC and randomization:
Subjects are screened for inclusion after TAVR. Consenting subjects must be randomized within 2-7 days (1-7 days after protocol amendment) after a successful TAVR and before hospital discharge.

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Addresses

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    • Bayer AG
    • D-13353  Berlin
    • Germany
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    •   +49 30 468 193460
    •   [---]*
    •   [---]*
    •   [---]*
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    • St.-Johannes-Hospital
    • Johannesstr. 9-13
    • 44137  Dortmund
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Cardialysis
    • Ms.  Sanne  Rijnders 
    • Westblaak 98
    • 3012 KM  Rotterdam
    • Netherlands
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Sources of Monetary or Material Support

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    • Bayer AG
    • 13348  Berlin
    • Germany
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    •   030 468 193460
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2018/11/16
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.