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

Transcatheter Aortic Valve Replacement Clinical Trial

— GALILEO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02556203
• Other study ID #: 17938
• Secondary ID: 2015-001975-30
• Status: Terminated
• Phase: Phase 3
• Start date: December 16, 2015
• Est. completion date: November 27, 2018

Study information

• Verified date: December 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1653
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
10mg OD (once-daily)
• Acetylsalicylic Acid (ASA)
75-100mg OD
• Clopidogrel
75mg OD
• Rivaroxaban (Xarelto, BAY59-7939)
In case of NOAF, 20/15 mg OD (once-daily)
• Vitamin K antagonist (VKA)
In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Death or First Thromboembolic Event (DTE)	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.	Through study completion, on average 14 months
Primary	Number of Participants With Death or First Thromboembolic Event (DTE)	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.	Through study completion, on average 16 months
Primary	Number of Participants With Primary Bleeding Event (PBE)	PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.	Through study completion, on average 16 months
Secondary	Number of Participants With Net-clinical Benefit	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).	Through study completion, on average 16 months
Secondary	Number of Participants With Cardiovascular Death or Thromboembolic Event	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).	Through study completion, on average 16 months
Secondary	Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds	Composite of TIMI major and minor bleedings	Through study completion, on average 16 months
Secondary	Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds	ISTH major bleeds	Through study completion, on average 16 months
Secondary	Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds	Composite of BARC 2,3 or 5 bleedings	Through study completion, on average 16 months

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