MedTrace Logo

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

NCT02556203 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1653

Last updated 2020-01-13

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-16
Primary Completion
2018-11-27
Completion
2018-11-27
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556203 on ClinicalTrials.gov