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
A 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
2 other identifiers
interventional
1,504
17 countries
178
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Oct 2012
Shorter than P25 for phase_3 atrial-fibrillation
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
February 3, 2015
CompletedApril 30, 2015
April 1, 2015
1.3 years
August 27, 2012
January 8, 2015
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Major Bleedings as Per Central Adjudication
Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (\>)1 total subjects were reported.
From randomization up to the date of the last dose of study drug + 2 days
Secondary Outcomes (9)
Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Strokes
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Transient Ischemic Attacks
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Non-central Nervous System Systemic Embolisms
From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
- +4 more secondary outcomes
Study Arms (2)
Rivaroxaban (Xarelto, BAY59-7939)
EXPERIMENTALA 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.
Vitamin K antagonist (VKA)
ACTIVE COMPARATORA 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.
Interventions
Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study
VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
Study Sites (178)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
East Palo Alto, California, 94303, United States
Unknown Facility
El Cajon, California, 92020, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
Santa Rosa, California, 95494, United States
Unknown Facility
Torrance, California, 90502-2004, United States
Unknown Facility
New Haven, Connecticut, 06520, United States
Unknown Facility
Stamford, Connecticut, 06905, United States
Unknown Facility
Wilmington, Delaware, 19803, United States
Unknown Facility
Clearwater, Florida, 33756, United States
Unknown Facility
Daytona Beach, Florida, 32117, United States
Unknown Facility
Deltona, Florida, 32725, United States
Unknown Facility
Fort Lauderdale, Florida, 33308, United States
Unknown Facility
Fort Lauderdale, Florida, 33316, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Lakeland, Florida, 33805, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
Miami, Florida, 33135, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Saint Augustine, Florida, 32216, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Savannah, Georgia, 31419, United States
Unknown Facility
Aurora, Illinois, 60504, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Elk Grove Village, Illinois, 60007, United States
Unknown Facility
Joliet, Illinois, 60435, United States
Unknown Facility
Rockford, Illinois, 61107, United States
Unknown Facility
Annapolis, Maryland, 21401, United States
Unknown Facility
Columbia, Maryland, 21044, United States
Unknown Facility
Rockville, Maryland, 20853, United States
Unknown Facility
Lincoln, Nebraska, 68516, United States
Unknown Facility
North Las Vegas, Nevada, 89086, United States
Unknown Facility
Bridgewater, New Jersey, 08807, United States
Unknown Facility
Manalapan, New Jersey, 07716, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
New York, New York, 10013, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Troy, New York, 12180, United States
Unknown Facility
Asheville, North Carolina, 28805, United States
Unknown Facility
Cantan, Ohio, 44708, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Mansfield, Ohio, 44906, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Beaver, Pennsylvania, 15009, United States
Unknown Facility
Butler, Pennsylvania, 16001, United States
Unknown Facility
Doylestown, Pennsylvania, 18901, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Johnson City, Tennessee, 37604, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Austin, Texas, 78745, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Fort Sam Houston, Texas, 78234-6200, United States
Unknown Facility
Tyler, Texas, 75701, United States
Unknown Facility
Layton, Utah, 84041, United States
Unknown Facility
Bellingham, Washington, 98225, United States
Unknown Facility
Burien, Washington, 98166, United States
Unknown Facility
Wausau, Wisconsin, 54401, United States
Unknown Facility
Leuven, Vlaams Brabant, 3000, Belgium
Unknown Facility
Bruxelles - Brussel, 1070, Belgium
Unknown Facility
Gilly, 6060, Belgium
Unknown Facility
Hasselt, 3500, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Mol, 2400, Belgium
Unknown Facility
Curitiba, Paraná, 80730-150, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Unknown Facility
Campinas, São Paulo, 13010-001, Brazil
Unknown Facility
Campinas, São Paulo, 13060904, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-900, Brazil
Unknown Facility
Edmonton, Alberta, T5H 3V9, Canada
Unknown Facility
Victoria, British Columbia, V8R 4R2, Canada
Unknown Facility
Saint John, New Brunswick, E2L 4L2, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Unknown Facility
Hamilton, Ontario, L8L 2X2, Canada
Unknown Facility
Toronto, Ontario, M5B 1W8, Canada
Unknown Facility
Montreal, Quebec, H1T 1C8, Canada
Unknown Facility
Montreal, Quebec, H2W 1T8, Canada
Unknown Facility
Québec, Quebec, G1V 4G5, Canada
Unknown Facility
Guangzhou, Guangdong, 510080, China
Unknown Facility
Wuhan, Hubei, China
Unknown Facility
Changsha, Hunan, 410011, China
Unknown Facility
Nanchang, Jiangxi, 330006, China
Unknown Facility
Changchun, Jilin, China
Unknown Facility
Xi'an, Shaanxi, 710061, China
Unknown Facility
Ürümqi, Xinjiang, China
Unknown Facility
Beijing, 100029, China
Unknown Facility
Shanghai, 200080, China
Unknown Facility
Shenyang, China
Unknown Facility
Hellerup, 2900, Denmark
Unknown Facility
Herning, 7400, Denmark
Unknown Facility
København NV, 2400, Denmark
Unknown Facility
Viborg, 8800, Denmark
Unknown Facility
Helsinki, FIN-00260, Finland
Unknown Facility
Jyväskylä, 40620, Finland
Unknown Facility
Lappeenranta, Finland
Unknown Facility
Oulu, Finland
Unknown Facility
Pori, 28500, Finland
Unknown Facility
Rovaniemi, 96101, Finland
Unknown Facility
Tampere, FIN-33520, Finland
Unknown Facility
Turku, 20521, Finland
Unknown Facility
Vaasa, 65130, Finland
Unknown Facility
Arras, 62000, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Paris, 75012, France
Unknown Facility
Paris, 75013, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Vandœuvre-lès-Nancy, 54500, France
Unknown Facility
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Unknown Facility
Nuremberg, Bavaria, 90471, Germany
Unknown Facility
Hamburg, Hamburg, 20246, Germany
Unknown Facility
Frankfurt am Main, Hesse, 60596, Germany
Unknown Facility
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45147, Germany
Unknown Facility
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Unknown Facility
Mainz, Rhineland-Palatinate, 55131, Germany
Unknown Facility
Dresden, Saxony, 01067, Germany
Unknown Facility
Leipzig, Saxony, 04289, Germany
Unknown Facility
Berlin, State of Berlin, 13353, Germany
Unknown Facility
Alexandroupoli, 68100, Greece
Unknown Facility
Attica / Athens, 11526, Greece
Unknown Facility
Heraklion, 711 10, Greece
Unknown Facility
Thessaloniki, 54642, Greece
Unknown Facility
Acquaviva delle Fonti, Bari, 70021, Italy
Unknown Facility
San Fermo della Battaglia, Como, 22020, Italy
Unknown Facility
San Donato Milanese, Milano, 20097, Italy
Unknown Facility
Mestre, Venezia, 30174, Italy
Unknown Facility
Ancona, 60126, Italy
Unknown Facility
Catania, 95126, Italy
Unknown Facility
Roma, 00169, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Arnhem, 6815 AD, Netherlands
Unknown Facility
Haarlem, 2035 RC, Netherlands
Unknown Facility
Heerlen, 6419 PC, Netherlands
Unknown Facility
Leeuwarden, 8934 AD, Netherlands
Unknown Facility
Maastricht, 6229 HX, Netherlands
Unknown Facility
Martinho Do Bispo, Coimbra District, 3041-801, Portugal
Unknown Facility
Faro, Faro District, 8000-386, Portugal
Unknown Facility
Carnaxide, Lisbon District, 2795-53, Portugal
Unknown Facility
Almada, 2801-951, Portugal
Unknown Facility
Lisbon, 1169-024, Portugal
Unknown Facility
Vila Nova de Gaia, 4434-502, Portugal
Unknown Facility
Singapore, 119228, Singapore
Unknown Facility
Singapore, 168752, Singapore
Unknown Facility
Singapore, 308433, Singapore
Unknown Facility
Singapore, 768828, Singapore
Unknown Facility
Alberton, Gauteng, 1449, South Africa
Unknown Facility
Soweto, Gauteng, 2013, South Africa
Unknown Facility
Cape Town, Western Cape, 7450, South Africa
Unknown Facility
Cape Town, Western Cape, 7505, South Africa
Unknown Facility
Kuils River, Western Cape, 7580, South Africa
Unknown Facility
Somerset West, Western Cape, 7130, South Africa
Unknown Facility
Worcester, Western Cape, 6850, South Africa
Unknown Facility
Bloemfontein, 9301, South Africa
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Sabadell, Barcelona, 08208, Spain
Unknown Facility
Granada, Granada, 18012, Spain
Unknown Facility
Madrid, Madrid, 28007, Spain
Unknown Facility
Majadahonda, Madrid, 28222, Spain
Unknown Facility
Pamplona, Pamplona, 31008, Spain
Unknown Facility
Chesterfield, Derbyshire, S44 5BL, United Kingdom
Unknown Facility
Bournemouth, Dorset, BH7 7DW, United Kingdom
Unknown Facility
Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom
Unknown Facility
Leicester, Leicestershire, LE3 9QP, United Kingdom
Unknown Facility
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Unknown Facility
Cliftonville, NN1 5BD, United Kingdom
Unknown Facility
London, SW17 0RE, United Kingdom
Unknown Facility
Portsmouth, PO6 3LY, United Kingdom
Related Publications (2)
Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.
PMID: 25182247BACKGROUNDHai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241. No abstract available.
PMID: 24944325BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bayer HealthCare AG
- Organization
- Bayer HealthCare AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2012
First Posted
August 29, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
April 30, 2015
Results First Posted
February 3, 2015
Record last verified: 2015-04