Galileo

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

Galileo [NCT02556203]

Description: 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 whether a rivaroxaban-based strategy, following TAVR, compared to an antiplatelet-based strategy, is non-inferior towards primary bleeding events (PBE).

 

Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: Acetylsalicylic acid, Drug: Clopidogrel

Primary Investigator: Kereiakes

Drug/Device Information
Comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortIc valve replacement to optimize clinical outcomes
Rivaroxaban is a potent and highly selective oral direct factor Xa inhibitor
Subjects will be randomly assigned in a 1:1 ratio to receive a rivaroxaban-based strategy or an antiplatelet-based strategy
This is an open-label trial
Rivaroxaban-based strategy (first 90 days) - Rivaroxaban 10 mg once-daily AND ASA 75-100 mg once-daily
Rivaroxaban-based strategy (after the first 90 days) - Rivaroxaban 10 mg once-daily alone, ASA 75-100 mg once-daily is discontinued
Antiplatelet-based strategy (first 90 days) - DAPT: clopidogrel 75 mg once-daily AND ASA 75-100 mg once daily
Antiplatelet-based strategy (after the first 90 days) - ASA 75-100 mg once-daily alone, Clopidogrel 75 mg once-daily is discontinued
Rivaroxaban dosing is adjusted OR clopidogrel is changed to VKA therapy if patient has new-onset atrial fibrillation - PLEASE CONTACT THE LINDNER CENTER
Bayer HealthCare AG