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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)

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01674647
First received: August 27, 2012
Last updated: February 19, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Vitamin K antagonist (VKA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Composite number of the following events, adjudicated centrally: stroke, transient ischemic attack, non-central nervous system systemic embolism, myocardial infarction and cardiovascular death [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of major bleedings as per central adjudication [ Time Frame: Up to 100 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite number of strokes and non-central nervous system systemic embolisms [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Composite number of strokes, transient ischemic attacks, non-central nervous system systemic embolisms, myocardial infarctions and all-cause mortality [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of strokes [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of transient ischemic attacks [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of non-central nervous system systemic embolisms [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of myocardial infarctions [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Number of cardiovascular deaths [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: Up to 100 days ] [ Designated as safety issue: No ]
  • Composite number of major and non-major bleeding events [ Time Frame: Up to 100 days ] [ Designated as safety issue: Yes ]

Enrollment: 1504
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
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.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
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
Active Comparator: Vitamin K antagonist (VKA)
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.
Drug: Vitamin K antagonist (VKA)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674647

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
East Palo Alto, California, United States, 94303
El Cajon, California, United States, 92020
National City, California, United States, 91950
Sacramento, California, United States, 95819
Santa Rosa, California, United States, 95494
Torrance, California, United States, 90502-2004
United States, Connecticut
New Haven, Connecticut, United States, 06520
Stamford, Connecticut, United States, 06905
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, Florida
Clearwater, Florida, United States, 33756
Daytona Beach, Florida, United States, 32117
Deltona, Florida, United States, 32725
Ft. Lauderdale, Florida, United States, 33308
Ft. Lauderdale, Florida, United States, 33316
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32216
Lakeland, Florida, United States, 33805
Melbourne, Florida, United States, 32901
Miami, Florida, United States, 33135
Orlando, Florida, United States, 32806
St. Augustine, Florida, United States, 32216
Tallahassee, Florida, United States, 32308
United States, Georgia
Savannah, Georgia, United States, 31419
United States, Illinois
Aurora, Illinois, United States, 60504
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Elk Grove Village, Illinois, United States, 60007
Joliet, Illinois, United States, 60435
Rockford, Illinois, United States, 61107
United States, Maryland
Annapolis, Maryland, United States, 21401
Columbia, Maryland, United States, 21044
Rockville, Maryland, United States, 20853
United States, Nebraska
Lincoln, Nebraska, United States, 68516
United States, Nevada
North Las Vegas, Nevada, United States, 89086
United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Manalapan, New Jersey, United States, 07716
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
Buffalo, New York, United States, 14215
New York, New York, United States, 10032
New York, New York, United States, 10013
Troy, New York, United States, 12180
United States, North Carolina
Asheville, North Carolina, United States, 28805
United States, Ohio
Cantan, Ohio, United States, 44708
Cleveland, Ohio, United States, 44195
Mansfield, Ohio, United States, 44906
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
Butler, Pennsylvania, United States, 16001
Doylestown, Pennsylvania, United States, 18901
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19102
Philadelphia, Pennsylvania, United States, 19141
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Johnson City, Tennessee, United States, 37604
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78745
Dallas, Texas, United States, 75231
Fort Sam Houston, Texas, United States, 78234-6200
Tyler, Texas, United States, 75701
United States, Utah
Layton, Utah, United States, 84041
United States, Washington
Bellingham, Washington, United States, 98225
Burien, Washington, United States, 98166
United States, Wisconsin
Wausau, Wisconsin, United States, 54401
Belgium
Leuven, Vlaams Brabant, Belgium, 3000
Bruxelles - Brussel, Belgium, 1070
Gilly, Belgium, 6060
Hasselt, Belgium, 3500
Liege, Belgium, 4000
MOL, Belgium, 2400
Brazil
Curitiba, Parana, Brazil, 80730-150
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Campinas, Sao Paulo, Brazil, 13010-001
Campinas, Sao Paulo, Brazil, 13060904
Sao Paulo, Brazil, 05403-900
Canada, Alberta
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Victoria, British Columbia, Canada, V8R 4R2
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Hamilton, Ontario, Canada, L8L 2X2
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Montreal, Quebec, Canada, H1T 1C8
Canada
Quebec, Canada, G1V 4G5
China, Guangdong
Guangzhou, Guangdong, China, 510080
China, Hubei
Wuhan, Hubei, China
China, Hunan
Changsha, Hunan, China, 410011
China, Jiangxi
Nanchang, Jiangxi, China, 330006
China, Jilin
Changchun, Jilin, China
China, Shaanxi
Xi'an, Shaanxi, China, 710061
China, Xinjiang
Urumqi, Xinjiang, China
China
Beijing, China, 100029
Shanghai, China, 200080
Shenyang, China
Denmark
Hellerup, Denmark, 2900
Herning, Denmark, 7400
København NV, Denmark, 2400
Viborg, Denmark, 8800
Finland
Helsinki, Finland, FIN-00260
Jyväskylä, Finland, 40620
Lappeenranta, Finland
Oulu, Finland
Pori, Finland, 28500
Rovaniemi, Finland, 96101
Tampere, Finland, FIN-33520
Turku, Finland, 20521
Vaasa, Finland, 65130
France
Arras, France, 62000
Lille Cedex, France, 59037
Paris, France, 75012
Paris, France, 75018
Paris cedex 13, France, 75013
Pessac, France, 33604
TOULOUSE cedex, France, 31059
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54500
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Nürnberg, Bayern, Germany, 90471
Frankfurt, Hessen, Germany, 60596
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Essen, Nordrhein-Westfalen, Germany, 45147
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Mainz, Rheinland-Pfalz, Germany, 55131
Dresden, Sachsen, Germany, 01067
Leipzig, Sachsen, Germany, 04289
Berlin, Germany, 13353
Hamburg, Germany, 20246
Greece
Alexandroupolis, Greece, 68100
Attica / Athens, Greece, 11526
Heraklion, Greece, 711 10
Thessaloniki, Greece, 54642
Italy
Acquaviva delle Fonti, Bari, Italy, 70021
San Fermo della Battaglia, Como, Italy, 22020
San Donato Milanese, Milano, Italy, 20097
Mestre, Venezia, Italy, 30174
Ancona, Italy, 60126
Catania, Italy, 95126
Roma, Italy, 00169
Torino, Italy, 10126
Netherlands
Arnhem, Netherlands, 6815 AD
Haarlem, Netherlands, 2035 RC
Heerlen, Netherlands, 6419 PC
Leeuwarden, Netherlands, 8934 AD
Maastricht, Netherlands, 6229 HX
Portugal
Martinho do Bispo, Coimbra, Portugal, 3041-801
Carnaxide, Lisboa, Portugal, 2795-53
Almada, Portugal, 2801-951
Faro, Portugal, 8000-386
Lisboa, Portugal, 1169-024
Vila Nova de Gaia, Portugal, 4434-502
Singapore
Singapore, Singapore, 768828
Singapore, Singapore, 168752
Singapore, Singapore, 119228
Singapore, Singapore, 308433
South Africa
Alberton, Gauteng, South Africa, 1449
Soweto, Gauteng, South Africa, 2013
Cape Town, Western Cape, South Africa, 7505
Cape Town, Western Cape, South Africa, 7450
Kuils River, Western Cape, South Africa, 7580
Somerset West, Western Cape, South Africa, 7130
Worcester, Western Cape, South Africa, 6850
Bloemfontein, South Africa, 9301
Spain
Sabadell, Barcelona, Spain, 08208
Majadahonda, Madrid, Spain, 28222
Barcelona, Spain, 08036
Granada, Spain, 18012
Madrid, Spain, 28007
Pamplona, Spain, 31008
United Kingdom
Chesterfield, Derbyshire, United Kingdom, S44 5BL
Bournemouth, Dorset, United Kingdom, BH7 7DW
Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
Leicester, Leicestershire, United Kingdom, LE3 9QP
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Cliftonville, United Kingdom, NN1 5BD
London, United Kingdom, SW17 0RE
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01674647     History of Changes
Other Study ID Numbers: 15693, 2011-002234-39
Study First Received: August 27, 2012
Last Updated: February 19, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
South Africa: Department of Health
Spain: Ministry of Health, Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
rivaroxaban
oral anticoagulant
nonvalvular atrial fibrillation
cardioversion
stroke
transient ischemic attack
thromboembolism
cardiovascular event

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Rivaroxaban
Vitamin K
Vitamins
Anticoagulants
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014