Completed

X-VERTA Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

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What is being tested

Rivaroxaban (Xarelto, BAY59-7939)

+ Vitamin K antagonist (VKA)

Drug
Who is being recruted

Arrhythmias, Cardiac+13

+ Brain Diseases

+ Cardiovascular Diseases

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorBayer
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

NCT01674647
Principal SponsorBayer
Last updated: April 30, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1504 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesBrain IschemiaCerebrovascular DisordersHeart DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesEmbolism and ThrombosisAtrial FibrillationIschemic Attack, TransientThromboembolismStroke

Criteria

4 inclusion criteria required to participate
Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
Men or women aged >= 18 years
Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
Women of childbearing potential and men must agree to use adequate contraception when sexually active
10 exclusion criteria prevent from participating
Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Acute Myocardial infarction (MI) within the last 14 days prior to randomization
Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.

Group II

Active Comparator
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 178 locations

Mobile, United StatesOpen in Google Maps

Scottsdale, United States

East Palo Alto, United States

El Cajon, United States
Completed178 Study Centers