check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

15693

ClinicalTrials.gov Identifier:

NCT01674647

EudraCT Number:

2011-002234-39

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
October 2012 - January 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Milano, 20097, Italy
Completed
Catania, 95126, Italy
Completed
Ancona, 60126, Italy
Completed
Como, 22020, Italy
Completed
Bari, 70021, Italy
Completed
Venezi, 30174, Italy
Completed
Torino, 10126, Italy
Completed
Roma, 00169, Italy
Completed
Kuils River, 7580, South Africa
Completed
Worcester, 6850, South Africa
Completed
Bloemfontein, 9301, South Africa
Completed
Cape Town, 7450, South Africa
Withdrawn
Cape Town, 7500, South Africa
Completed
Cape Town, 7450, South Africa
Completed
SOWETO, 2013, South Africa
Completed
Somerset West, 7130, South Africa
Completed
Alberton, 1449, South Africa
Completed
Majadahonda, 28222, Spain
Completed
Barcelona, 08036, Spain
Completed
Granada, 18012, Spain
Completed
Pamplona, 31008, Spain
Completed
Sabadell, 08208, Spain
Completed
Heraklion, 711 10, Greece
Completed
Thessaloniki, 54642, Greece
Completed
Alexandroupolis, 68100, Greece
Completed
Attica / Athens, 11526, Greece
Withdrawn
Curitiba, 80730-150, Brazil
Withdrawn
Campinas, 13010-001, Brazil
Completed
Viborg, 8800, Denmark
Completed
Herning, 7400, Denmark
Completed
Hellerup, 2900, Denmark
Completed
København NV, 2400, Denmark
Completed
HEERLEN, 6419 PC, Netherlands
Completed
MAASTRICHT, 6229 HX, Netherlands
Completed
LEEUWARDEN, 8934 AD, Netherlands
Completed
Welwyn Garden City, AL7 4HQ, United Kingdom
Completed
ARNHEM, 6815 AD, Netherlands
Completed
HAARLEM, 2035 RC, Netherlands
Completed
Frankfurt, 60596, Germany
Completed
Mönchengladbach, 41063, Germany
Completed
Montreal, H1T 1C8, Canada
Withdrawn
Mansfield, 44906, United States
Withdrawn
Porto Alegre, 90610-000, Brazil
Withdrawn
Sao Paulo, 05403-900, Brazil
Withdrawn
Campinas, 13060904, Brazil
Completed
Turku, 20521, Finland
Completed
Lappeenranta, Finland
Completed
Pori, 28500, Finland
Completed
Jyväskylä, 40620, Finland
Withdrawn
Rovaniemi, 96101, Finland
Completed
Oulu, Finland
Completed
Berlin, 13353, Germany
Withdrawn
Saint John, E2L 4L2, Canada
Withdrawn
Quebec, G1V 4G5, Canada
Completed
Edmonton, T5H 3V9, Canada
Completed
LEUVEN, 3000, Belgium
Completed
Singapore, 168752, Singapore
Completed
Singapore, 308433, Singapore
Completed
Singapore, 768828, Singapore
Completed
Toronto, M5B 1W8, Canada
Completed
Hamilton, L8L 2X2, Canada
Completed
LILLE, 59000, France
Completed
ARRAS, 62000, France
Withdrawn
PARIS, 75018, France
Completed
Paris cedex 13, 75013, France
Withdrawn
PESSAC, 33604, France
Completed
TOULOUSE cedex, 31059, France
Completed
VANDOEUVRE-LES-NANCY, 54511, France
Completed
Vila Nova de Gaia, 4434-502, Portugal
Completed
Lisboa, 1169-024, Portugal
Completed
Almada, 2801-951, Portugal
Completed
Carnaxide, 2795-53, Portugal
Completed
Faro, 8000-386, Portugal
Completed
Sao Martinho do Bispo, 3041-801, Portugal
Completed
Essen, 45147, Germany
Completed
Hamburg, 20246, Germany
Completed
Freiburg, 79106, Germany
Completed
Bad Oeynhausen, 32545, Germany
Completed
Bournemouth, BH7 7DW, United Kingdom
Completed
Portsmouth, PO6 3LY, United Kingdom
Completed
Chesterfield, S44 5DX, United Kingdom
Completed
Leicester, LE3 9QP, United Kingdom
Completed
Nottingham, NG5 1PB, United Kingdom
Completed
Cliftonville, NN1 5BD, United Kingdom
Completed
London, SW17 0RE, United Kingdom
Completed
Rapid City, 57701, United States
Completed
Lincoln, 68506, United States
Completed
Mobile, 36608, United States
Withdrawn
Aurora, 60504, United States
Completed
Tallahassee, 32308, United States
Completed
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
HASSELT, 3500, Belgium
Completed
LIEGE, 4000, Belgium
Completed
MOL, 2400, Belgium
Completed
GILLY, 6060, Belgium
Completed
Vaasa, 65130, Finland
Completed
Tampere, FIN-33520, Finland
Completed
Singapore, 119228, Singapore
Completed
Somerset West, 7130, South Africa
Completed
Canton, 44710, United States
Completed
Buffalo, 14215, United States
Withdrawn
Santa Rosa, 95494, United States
Completed
Miramar, 33025, United States
Withdrawn
Columbia, 21044, United States
Completed
Sacramento, 95819, United States
Withdrawn
Johnson City, 37604, United States
Completed
Doylestown, 18901, United States
Completed
Wausau, 54401, United States
Completed
National City, 91950, United States
Completed
El Cajon, 92020, United States
Withdrawn
Chicago, 60612, United States
Completed
Madrid, 28007, Spain
Completed
Montreal, H2W 1T8, Canada
Withdrawn
East Palo Alto, 94303, United States
Withdrawn
Elk Grove Village, 60007, United States
Completed
Rockford, 61107, United States
Completed
New York, 10032, United States
Completed
Dresden, 01067, Germany
Completed
Scottsdale, 85258, United States
Completed
Nürnberg, 90471, Germany
Completed
Leipzig, 04289, Germany
Withdrawn
Asheville, 28805, United States
Completed
Toledo, 43623, United States
Completed
Albuquerque, 87102, United States
Withdrawn
North Las Vegas, 89086, United States
Completed
Stamford, 06905, United States
Withdrawn
Bellingham, 98225, United States
Withdrawn
Beaver, 15009, United States
Withdrawn
Burien, 98166, United States
Completed
Butler, 16001, United States
Completed
Helsinki, FIN-00260, Finland
Completed
Victoria, V8R 4R2, Canada
Withdrawn
Nashville, 37203, United States
Completed
Layton, 84041, United States
Withdrawn
Nashville, 37232, United States
Completed
Cleveland, 44195, United States
Withdrawn
Dallas, 75231, United States
Completed
Tyler, 75701, United States
Completed
Clearwater, 33756, United States
Withdrawn
New York, 10013, United States
Completed
Deltona, 32725, United States
Withdrawn
Rockville, 20853, United States
Completed
Ft. Lauderdale, 33316, United States
Completed
Bridgewater, 08807, United States
Completed
Daytona Beach, 32117, United States
Completed
Fort Sam Houston, 78234-6200, United States
Completed
Wilmington, 19803, United States
Completed
Philadelphia, 19141, United States
Withdrawn
Chicago, 60637, United States
Completed
Hershey, 17033, United States
Withdrawn
Ft. Lauderdale, 33308, United States
Completed
Annapolis, 21401, United States
Completed
Beijing, 100029, China
Completed
Xi'an, 710061, China
Withdrawn
Philadelphia, 19102, United States
Completed
Orlando, 32806, United States
Completed
Shenyang, 110016, China
Completed
Wuhan, China
Completed
Urumqi, 830054, China
Withdrawn
Changsha, 410011, China
Completed
Guangzhou, 510080, China
Completed
Nanchang, 330006, China
Withdrawn
Shanghai, 200080, China
Completed
Changchun, 130021, China
Completed
Torrance, 90502, United States
Completed
Troy, 12180, United States
Completed
Manalapan, 07716, United States
Completed
Austin, 78745, United States
Completed
New Haven, 06520, United States
Completed
Melbourne, 32901, United States
Completed
St. Augustine, 32086, United States
Completed
Jacksonville, 32216, United States
Completed
Joliet, 60435, United States
Completed
Jacksonville, 32216, United States
Withdrawn
Miami, 33135, United States
Withdrawn
Lakeland, 33805, United States
Withdrawn
Savannah, 31419, United States
Completed
TOURS, 37044, France
Completed
PARIS, 75012, France
Completed
Mainz, 55131, Germany
Completed
St. John's, A1B 3V6, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    From randomization up to the date of the last dose of study drug + 2 days
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with composite of strokes and non-central nervous system systemic embolisms
    Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. 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). Number of subjects with composite events were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with composite of strokes, transient ischemic attacks, non-central nervous system systemic embolisms, myocardial infarctions and all-cause mortality
    Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by 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. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with strokes
    All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with transient ischemic attacks
    All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with non-central nervous system systemic embolisms
    All events were adjudicated and confirmed by a CEC blinded to treatment. 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). Number of subjects with non-CNS embolism were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with myocardial infarctions
    All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with cardiovascular deaths
    All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with all-cause mortality
    All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with composite of major and non-major bleeding events
    All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, 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) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.
    date_rangeTime Frame:
    From randomization up to the date of the last dose of study drug + 2 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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