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

Bayer

Status and phase: Terminated; Phase 3

Conditions: Transcatheter Aortic Valve Replacement

Treatments: Drug: Vitamin K antagonist (VKA); Drug: Clopidogrel; Drug: Acetylsalicylic Acid (ASA); Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02556203

17938

2015-001975-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,653 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,653 participants in 2 patient groups

Rivaroxaban (Xarelto, BAY59-7939)

Experimental group

Description:

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.

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Acetylsalicylic Acid (ASA)

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Antiplatelet

Active Comparator group

Description:

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.

Treatment:

Drug: Acetylsalicylic Acid (ASA)

Drug: Clopidogrel

Drug: Vitamin K antagonist (VKA)