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
This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Bayer
Collaborator:
Janssen Research & Development, LLC
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01674647
First received: August 27, 2012
Last updated: April 25, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674647
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Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
| Contact: For trial location information: (Phone Menu Options '3' or '4') | (+)1-888-84 22397 |
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| United States, Alabama | |
| Recruiting | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Not yet recruiting | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Terminated | |
| East Palo Alto, California, United States, 94303 | |
| Recruiting | |
| El Cajon, California, United States, 92020 | |
| Recruiting | |
| National City, California, United States, 91950 | |
| Recruiting | |
| Sacramento, California, United States, 95819 | |
| Terminated | |
| Santa Rosa, California, United States, 95494 | |
| Not yet recruiting | |
| Torrance, California, United States, 90502-2004 | |
| United States, Connecticut | |
| Not yet recruiting | |
| New Haven, Connecticut, United States, 06520 | |
| Recruiting | |
| Stamford, Connecticut, United States, 06905 | |
| United States, Delaware | |
| Not yet recruiting | |
| Wilmington, Delaware, United States, 19803 | |
| United States, Florida | |
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| Daytona Beach, Florida, United States, 32117 | |
| Not yet recruiting | |
| Deltona, Florida, United States, 32725 | |
| Terminated | |
| Ft. Lauderdale, Florida, United States, 33308 | |
| Not yet recruiting | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Recruiting | |
| Hollywood, Florida, United States, 33021 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Lakeland, Florida, United States, 33805 | |
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| Largo, Florida, United States, 33770 | |
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| Melbourne, Florida, United States, 32901 | |
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| Miami, Florida, United States, 33135 | |
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| Orlando, Florida, United States, 32806 | |
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| St. Augustine, Florida, United States, 32086 | |
| Recruiting | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Not yet recruiting | |
| Savannah, Georgia, United States, 31405 | |
| United States, Illinois | |
| Terminated | |
| Aurora, Illinois, United States, 60504 | |
| Terminated | |
| Chicago, Illinois, United States, 60612 | |
| Not yet recruiting | |
| Chicago, Illinois, United States, 60637 | |
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| Elk Grove Village, Illinois, United States, 60007 | |
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| Joliet, Illinois, United States, 60435 | |
| Recruiting | |
| Rockford, Illinois, United States, 61107 | |
| United States, Maryland | |
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| Annapolis, Maryland, United States, 21401 | |
| Terminated | |
| Columbia, Maryland, United States, 21044 | |
| Terminated | |
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| Lincoln, Nebraska, United States, 68516 | |
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| Manalapan, New Jersey, United States, 07716 | |
| United States, New Mexico | |
| Recruiting | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Recruiting | |
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| Not yet recruiting | |
| New York, New York, United States, 10032 | |
| Terminated | |
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| Troy, New York, United States, 12180 | |
| United States, North Carolina | |
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| Asheville, North Carolina, United States, 28805 | |
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| Cantan, Ohio, United States, 44708 | |
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| Cleveland, Ohio, United States, 44195 | |
| Terminated | |
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| Recruiting | |
| Toledo, Ohio, United States, 43623 | |
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| Beaver, Pennsylvania, United States, 15009 | |
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| Recruiting | |
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| United States, South Dakota | |
| Recruiting | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Terminated | |
| Johnson City, Tennessee, United States, 37604 | |
| Terminated | |
| Nashville, Tennessee, United States, 37203 | |
| Not yet recruiting | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
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| Austin, Texas, United States, 78745 | |
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| Dallas, Texas, United States, 75231 | |
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| Fort Sam Houston, Texas, United States, 78234-6200 | |
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| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| Recruiting | |
| Layton, Utah, United States, 84041 | |
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| United States, Wisconsin | |
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| Wausau, Wisconsin, United States, 54401 | |
| Belgium | |
| Recruiting | |
| Leuven, Vlaams Brabant, Belgium, 3000 | |
| Recruiting | |
| Bruxelles - Brussel, Belgium, 1070 | |
| Recruiting | |
| Gilly, Belgium, 6060 | |
| Recruiting | |
| Hasselt, Belgium, 3500 | |
| Recruiting | |
| Liege, Belgium, 4000 | |
| Recruiting | |
| MOL, Belgium, 2400 | |
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| Not yet recruiting | |
| Curitiba, Parana, Brazil, 80730-150 | |
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| Not yet recruiting | |
| Campinas, Sao Paulo, Brazil, 13010-001 | |
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| Campinas, Sao Paulo, Brazil, 13060904 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 05403-900 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Canada, British Columbia | |
| Not yet recruiting | |
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| Canada, Ontario | |
| Recruiting | |
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| Recruiting | |
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| Canada, Quebec | |
| Recruiting | |
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| Canada | |
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| Quebec, Canada, G1V 4G5 | |
| China, Guangdong | |
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| China, Hunan | |
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| China, Jiangxi | |
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| China, Jilin | |
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| China, Shaanxi | |
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| Beijing, China, 100029 | |
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| Shenyang, China | |
| Denmark | |
| Recruiting | |
| Hellerup, Denmark, 2900 | |
| Recruiting | |
| Herning, Denmark, 7400 | |
| Recruiting | |
| København NV, Denmark, 2400 | |
| Recruiting | |
| Viborg, Denmark, 8800 | |
| Finland | |
| Not yet recruiting | |
| Helsinki, Finland, FIN-00260 | |
| Not yet recruiting | |
| Jyväskylä, Finland, 40620 | |
| Recruiting | |
| Lappeenranta, Finland | |
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| Oulu, Finland | |
| Recruiting | |
| Pori, Finland, 28500 | |
| Not yet recruiting | |
| Rovaniemi, Finland, 96101 | |
| Recruiting | |
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| Turku, Finland, 20521 | |
| Recruiting | |
| Vaasa, Finland, 65130 | |
| France | |
| Recruiting | |
| Arras, France, 62000 | |
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| Lille Cedex, France, 59037 | |
| Not yet recruiting | |
| Paris, France, 75018 | |
| Recruiting | |
| Paris cedex 13, France, 75013 | |
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| Pessac, France, 33604 | |
| Recruiting | |
| TOULOUSE cedex, France, 31059 | |
| Recruiting | |
| Vandoeuvre-les-nancy, France, 54500 | |
| Germany | |
| Recruiting | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Recruiting | |
| Nürnberg, Bayern, Germany, 90471 | |
| Recruiting | |
| Frankfurt, Hessen, Germany, 60596 | |
| Recruiting | |
| Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545 | |
| Recruiting | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Recruiting | |
| Mönchengladbach, Nordrhein-Westfalen, Germany, 41063 | |
| Recruiting | |
| Dresden, Sachsen, Germany, 01067 | |
| Recruiting | |
| Leipzig, Sachsen, Germany, 04289 | |
| Recruiting | |
| Berlin, Germany, 13353 | |
| Recruiting | |
| Hamburg, Germany, 20246 | |
| Greece | |
| Not yet recruiting | |
| Alexandroupolis, Greece, 68100 | |
| Not yet recruiting | |
| Attica / Athens, Greece, 11526 | |
| Recruiting | |
| Heraklion, Greece, 711 10 | |
| Not yet recruiting | |
| Thessaloniki, Greece, 54642 | |
| Italy | |
| Recruiting | |
| Acquaviva delle Fonti, Bari, Italy, 70021 | |
| Recruiting | |
| San Fermo della Battaglia, Como, Italy, 22020 | |
| Recruiting | |
| San Donato Milanese, Milano, Italy, 20097 | |
| Recruiting | |
| Mestre, Venezia, Italy, 30174 | |
| Recruiting | |
| Ancona, Italy, 60126 | |
| Recruiting | |
| Catania, Italy, 95126 | |
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| Roma, Italy, 00169 | |
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| Torino, Italy, 10126 | |
| Netherlands | |
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| Arnhem, Netherlands, 6815 AD | |
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| Haarlem, Netherlands, 2035 RC | |
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| Heerlen, Netherlands, 6419 PC | |
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| Leeuwarden, Netherlands, 8934 AD | |
| Recruiting | |
| Maastricht, Netherlands, 6229 HX | |
| Portugal | |
| Recruiting | |
| Martinho do Bispo, Coimbra, Portugal, 3041-801 | |
| Recruiting | |
| Carnaxide, Lisboa, Portugal, 2795-53 | |
| Recruiting | |
| Almada, Portugal, 2801-951 | |
| Recruiting | |
| Faro, Portugal, 8000-386 | |
| Recruiting | |
| Lisboa, Portugal, 1169-024 | |
| Recruiting | |
| Vila Nova de Gaia, Portugal, 4434-502 | |
| Singapore | |
| Recruiting | |
| Singapore, Singapore, 168752 | |
| Not yet recruiting | |
| Singapore, Singapore, 308433 | |
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| Singapore, Singapore, 768828 | |
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| Singapore, Singapore, 119228 | |
| South Africa | |
| Recruiting | |
| Alberton, Gauteng, South Africa, 1449 | |
| Not yet recruiting | |
| Soweto, Gauteng, South Africa, 2013 | |
| Recruiting | |
| Cape Town, Western Cape, South Africa, 7450 | |
| Not yet recruiting | |
| Cape Town, Western Cape, South Africa, 7505 | |
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| Kuils River, Western Cape, South Africa, 7580 | |
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| Somerset West, Western Cape, South Africa, 7130 | |
| Recruiting | |
| Worcester, Western Cape, South Africa, 6850 | |
| Recruiting | |
| Bloemfontein, South Africa, 9301 | |
| Spain | |
| Recruiting | |
| Sabadell, Barcelona, Spain, 08208 | |
| Recruiting | |
| Majadahonda, Madrid, Spain, 28222 | |
| Recruiting | |
| Barcelona, Spain, 08036 | |
| Recruiting | |
| Granada, Spain, 18012 | |
| Not yet recruiting | |
| Madrid, Spain, 28007 | |
| Recruiting | |
| Pamplona, Spain, 31008 | |
| United Kingdom | |
| Recruiting | |
| Chesterfield, Derbyshire, United Kingdom, S44 5BL | |
| Recruiting | |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Recruiting | |
| Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ | |
| Recruiting | |
| Leicester, Leicestershire, United Kingdom, LE3 9QP | |
| Recruiting | |
| Northampton, Northamptonshire, United Kingdom, NN1 5BD | |
| Recruiting | |
| Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
| Recruiting | |
| London, United Kingdom, SW17 0RE | |
| Recruiting | |
| 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: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01674647 History of Changes |
| Other Study ID Numbers: | 15693, 2011-002234-39 |
| Study First Received: | August 27, 2012 |
| Last Updated: | April 25, 2013 |
| 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 Heart Diseases Cardiovascular Diseases Pathologic Processes Vitamin K Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013