Trial Condition(s):

Atrial Fibrillation

Explore the efficacy and safety of once-daily oral rivaroxaban for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion (X-VERT)

Bayer Identifier:

15693

ClinicalTrials.gov Identifier:

NCT01674647

EudraCT Number:

2011-002234-39

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Men or women aged >= 18 years
 - Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
 - 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
Exclusion Criteria
- Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
 - Transient ischemic attack within 3 days prior to randomization
 - Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
 - Acute Myocardial infarction (MI) within the last 14 days prior to randomization
 - Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation 
 - Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
 - Concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used systemically
 - Concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
 - Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
 - Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Trial Summary

Enrollment Goal
1504
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Milano, Italy, 20097

Status
Completed
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Catania, Italy, 95126

Status
Completed
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Ancona, Italy, 60126

Status
Completed
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Como, Italy, 22020

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Completed
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Bari, Italy, 70021

Status
Completed
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Venezi, Italy, 30174

Status
Completed
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Torino, Italy, 10126

Status
Completed
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Roma, Italy, 00169

Status
Completed
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Kuils River, South Africa, 7580

Status
Completed
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Worcester, South Africa, 6850

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Completed
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Bloemfontein, South Africa, 9301

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Completed
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Cape Town, South Africa, 7450

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Completed
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SOWETO, South Africa, 2013

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Completed
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Somerset West, South Africa, 7130

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Completed
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Alberton, South Africa, 1449

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Completed
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Majadahonda, Spain, 28222

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Completed
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Barcelona, Spain, 08036

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Completed
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Granada, Spain, 18012

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Completed
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Pamplona, Spain, 31008

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Completed
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Sabadell, Spain, 08208

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Completed
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Heraklion, Greece, 711 10

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Completed
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Thessaloniki, Greece, 54642

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Completed
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Alexandroupolis, Greece, 68100

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Completed
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Attica / Athens, Greece, 11526

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Completed
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Viborg, Denmark, 8800

Status
Completed
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Herning, Denmark, 7400

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Completed
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Hellerup, Denmark, 2900

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Completed
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København NV, Denmark, 2400

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Completed
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HEERLEN, Netherlands, 6419 PC

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Completed
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MAASTRICHT, Netherlands, 6229 HX

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Completed
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LEEUWARDEN, Netherlands, 8934 AD

Status
Completed
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Welwyn Garden City, United Kingdom, AL7 4HQ

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Completed
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ARNHEM, Netherlands, 6815 AD

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Completed
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HAARLEM, Netherlands, 2035 RC

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Completed
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Frankfurt, Germany, 60596

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Completed
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Mönchengladbach, Germany, 41063

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Completed
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Montreal, Canada, H1T 1C8

Status
Completed
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Turku, Finland, 20521

Status
Completed
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Lappeenranta, Finland

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Completed
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Pori, Finland, 28500

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Completed
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Jyväskylä, Finland, 40620

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Completed
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Oulu, Finland

Status
Completed
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Berlin, Germany, 13353

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Completed
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Edmonton, Canada, T5H 3V9

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Completed
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LEUVEN, Belgium, 3000

Status
Completed
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Singapore, Singapore, 168752

Status
Completed
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Singapore, Singapore, 308433

Status
Completed
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Singapore, Singapore, 768828

Status
Completed
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Toronto, Canada, M5B 1W8

Status
Completed
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Hamilton, Canada, L8L 2X2

Status
Completed
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LILLE, France, 59000

Status
Completed
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ARRAS, France, 62000

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Completed
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Paris cedex 13, France, 75013

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Completed
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TOULOUSE cedex, France, 31059

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Completed
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VANDOEUVRE-LES-NANCY, France, 54511

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Completed
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Vila Nova de Gaia, Portugal, 4434-502

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Completed
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Lisboa, Portugal, 1169-024

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Completed
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Almada, Portugal, 2801-951

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Completed
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Carnaxide, Portugal, 2795-53

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Completed
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Faro, Portugal, 8000-386

Status
Completed
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Sao Martinho do Bispo, Portugal, 3041-801

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Completed
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Essen, Germany, 45147

Status
Completed
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Hamburg, Germany, 20246

Status
Completed
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Freiburg, Germany, 79106

Status
Completed
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Bad Oeynhausen, Germany, 32545

Status
Completed
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Bournemouth, United Kingdom, BH7 7DW

Status
Completed
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Portsmouth, United Kingdom, PO6 3LY

Status
Completed
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Chesterfield, United Kingdom, S44 5DX

Status
Completed
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Leicester, United Kingdom, LE3 9QP

Status
Completed
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Nottingham, United Kingdom, NG5 1PB

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Completed
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Cliftonville, United Kingdom, NN1 5BD

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Completed
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London, United Kingdom, SW17 0RE

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Completed
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Rapid City, United States, 57701

Status
Completed
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Lincoln, United States, 68506

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Completed
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Mobile, United States, 36608

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Completed
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Tallahassee, United States, 32308

Status
Completed
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Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
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HASSELT, Belgium, 3500

Status
Completed
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LIEGE, Belgium, 4000

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Completed
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MOL, Belgium, 2400

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Completed
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GILLY, Belgium, 6060

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Completed
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Vaasa, Finland, 65130

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Completed
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Tampere, Finland, FIN-33520

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Completed
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Singapore, Singapore, 119228

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Completed
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Canton, United States, 44710

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Completed
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Buffalo, United States, 14215

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Completed
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Miramar, United States, 33025

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Completed
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Sacramento, United States, 95819

Status
Completed
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Doylestown, United States, 18901

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Completed
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Wausau, United States, 54401

Status
Completed
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National City, United States, 91950

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Completed
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El Cajon, United States, 92020

Status
Completed
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Madrid, Spain, 28007

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Completed
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Montreal, Canada, H2W 1T8

Status
Completed
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Rockford, United States, 61107

Status
Completed
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New York, United States, 10032

Status
Completed
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Dresden, Germany, 01067

Status
Completed
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Scottsdale, United States, 85258

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Completed
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Nürnberg, Germany, 90471

Status
Completed
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Leipzig, Germany, 04289

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Completed
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Toledo, United States, 43623

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Completed
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Albuquerque, United States, 87102

Status
Completed
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Stamford, United States, 06905

Status
Completed
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Butler, United States, 16001

Status
Completed
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Investigative Site

Helsinki, Finland, FIN-00260

Status
Completed
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Investigative Site

Victoria, Canada, V8R 4R2

Status
Completed
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Investigative Site

Layton, United States, 84041

Status
Completed
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Investigative Site

Cleveland, United States, 44195

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Completed
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Tyler, United States, 75701

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Completed
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Investigative Site

Clearwater, United States, 33756

Status
Completed
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Investigative Site

Deltona, United States, 32725

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Completed
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Investigative Site

Ft. Lauderdale, United States, 33316

Status
Completed
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Bridgewater, United States, 08807

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Completed
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Investigative Site

Daytona Beach, United States, 32117

Status
Completed
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Investigative Site

Fort Sam Houston, United States, 78234-6200

Status
Completed
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Investigative Site

Wilmington, United States, 19803

Status
Completed
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Investigative Site

Philadelphia, United States, 19141

Status
Completed
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Hershey, United States, 17033

Status
Completed
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Investigative Site

Annapolis, United States, 21401

Status
Completed
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Investigative Site

Beijing, China, 100029

Status
Completed
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Investigative Site

Xi'an, China, 710061

Status
Completed
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Investigative Site

Orlando, United States, 32806

Status
Completed
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Investigative Site

Shenyang, China, 110016

Status
Completed
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Investigative Site

Wuhan, China

Status
Completed
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Investigative Site

Urumqi, China, 830054

Status
Completed
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Investigative Site

Guangzhou, China, 510080

Status
Completed
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Investigative Site

Nanchang, China, 330006

Status
Completed
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Investigative Site

Changchun, China, 130021

Status
Completed
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Investigative Site

Torrance, United States, 90502

Status
Completed
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Investigative Site

Troy, United States, 12180

Status
Completed
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Investigative Site

Manalapan, United States, 07716

Status
Completed
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Investigative Site

Austin, United States, 78745

Status
Completed
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Investigative Site

New Haven, United States, 06520

Status
Completed
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Investigative Site

Melbourne, United States, 32901

Status
Completed
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Investigative Site

St. Augustine, United States, 32086

Status
Completed
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Investigative Site

Jacksonville, United States, 32216

Status
Completed
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Investigative Site

Joliet, United States, 60435

Status
Completed
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Investigative Site

TOURS, France, 37044

Status
Completed
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Investigative Site

PARIS, France, 75012

Status
Completed
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Investigative Site

Mainz, Germany, 55131

Status
Completed
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Investigative Site

St. John's, Canada, A1B 3V6

Status
Completed

Trial Design