NCT02556203

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,653 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

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

Timeline

• Start date: 2015-12-16
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2015-09-22
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

140 sites across 17 countries: United States, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, South Korea, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study