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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
  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 antiplateletbased strategy, following TAVR.


Condition Intervention Phase
Transcatheter Aortic Valve Replacement Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Acetylsalicylic acid Drug: Clopidogrel Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1520
Actual Study Start Date: December 16, 2015
Estimated Study Completion Date: November 30, 2018
Estimated Primary Completion Date: November 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban + ASA
Rivaroxaban + ASA (Acetylsalicylic acid) followed by rivaroxaban alone
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)
Active Comparator: ASA + Clopidogrel
ASA + Clopidogrel followed by ASA alone
Drug: Acetylsalicylic acid
75 - 100 mg OD (for first 90 days only in arm 1)
Drug: Clopidogrel
75 mg OD for first 90 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


Contacts
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

  Show 171 Study Locations
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02556203     History of Changes
Other Study ID Numbers: 17938
2015-001975-30 ( EudraCT Number )
First Submitted: September 5, 2015
First Posted: September 22, 2015
Last Update Posted: October 23, 2017
Last Verified: October 2017

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:
Clopidogrel
Aspirin
Rivaroxaban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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
Antipyretics