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)

April 10, 2015 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1504

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Gilly, Belgium, 6060
      • Hasselt, Belgium, 3500
      • Liege, Belgium, 4000
      • MOL, Belgium, 2400
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
  • Brazil
      • Sao Paulo, Brazil, 05403-900
    • Parana
      • Curitiba, Parana, Brazil, 80730-150
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13010-001
      • Campinas, Sao Paulo, Brazil, 13060904
  • Canada
      • Quebec, Canada, G1V 4G5
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • Toronto, Ontario, Canada, M5B 1W8
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2W 1T8
  • China
      • Beijing, China, 100029
      • Shanghai, China, 200080
      • Shenyang, China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
    • Hubei
      • Wuhan, Hubei, China
    • Hunan
      • Changsha, Hunan, China, 410011
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
    • Jilin
      • Changchun, Jilin, China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
    • Xinjiang
      • Urumqi, Xinjiang, 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, 75018
      • Paris, France, 75012
      • Paris cedex 13, France, 75013
      • Pessac, France, 33604
      • TOULOUSE cedex, France, 31059
      • Tours, France, 37044
      • Vandoeuvre-les-nancy, France, 54500
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
    • Bayern
      • Nürnberg, Bayern, Germany, 90471
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Sachsen
      • Dresden, Sachsen, Germany, 01067
      • Leipzig, Sachsen, Germany, 04289
  • Greece
      • Alexandroupolis, Greece, 68100
      • Attica / Athens, Greece, 11526
      • Heraklion, Greece, 711 10
      • Thessaloniki, Greece, 54642
  • Italy
      • Ancona, Italy, 60126
      • Catania, Italy, 95126
      • Roma, Italy, 00169
      • Torino, Italy, 10126
    • Bari
      • Acquaviva delle Fonti, Bari, Italy, 70021
    • Como
      • San Fermo della Battaglia, Como, Italy, 22020
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
    • Venezia
      • Mestre, Venezia, Italy, 30174
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
      • Haarlem, Netherlands, 2035 RC
      • Heerlen, Netherlands, 6419 PC
      • Leeuwarden, Netherlands, 8934 AD
      • Maastricht, Netherlands, 6229 HX
  • Portugal
      • Almada, Portugal, 2801-951
      • Faro, Portugal, 8000-386
      • Lisboa, Portugal, 1169-024
      • Vila Nova de Gaia, Portugal, 4434-502
    • Coimbra
      • Martinho do Bispo, Coimbra, Portugal, 3041-801
    • Lisboa
      • Carnaxide, Lisboa, Portugal, 2795-53
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 168752
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 768828
  • South Africa
      • Bloemfontein, South Africa, 9301
    • Gauteng
      • Alberton, Gauteng, South Africa, 1449
      • Soweto, Gauteng, South Africa, 2013
    • Western Cape
      • 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
  • Spain
      • Barcelona, Spain, 08036
      • Granada, Spain, 18012
      • Madrid, Spain, 28007
      • Pamplona, Spain, 31008
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
  • United Kingdom
      • Cliftonville, United Kingdom, NN1 5BD
      • London, United Kingdom, SW17 0RE
      • Portsmouth, United Kingdom, PO6 3LY
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5BL
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
    • Hertfordshire
      • Welwyn Garden City, Hertfordshire, United Kingdom, AL7 4HQ
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • 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
    • Connecticut
      • New Haven, Connecticut, United States, 06520
      • Stamford, Connecticut, United States, 06905
    • Delaware
      • Wilmington, Delaware, United States, 19803
    • Florida
      • Clearwater, Florida, United States, 33756
      • Daytona Beach, Florida, United States, 32117
      • Deltona, Florida, United States, 32725
      • Ft. Lauderdale, Florida, United States, 33316
      • Ft. Lauderdale, Florida, United States, 33308
      • 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
    • Georgia
      • Savannah, Georgia, United States, 31419
    • Illinois
      • Aurora, Illinois, United States, 60504
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
      • Elk Grove Village, Illinois, United States, 60007
      • Joliet, Illinois, United States, 60435
      • Rockford, Illinois, United States, 61107
    • Maryland
      • Annapolis, Maryland, United States, 21401
      • Columbia, Maryland, United States, 21044
      • Rockville, Maryland, United States, 20853
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
    • Nevada
      • North Las Vegas, Nevada, United States, 89086
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
      • Manalapan, New Jersey, United States, 07716
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • 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
    • North Carolina
      • Asheville, North Carolina, United States, 28805
    • Ohio
      • Cantan, Ohio, United States, 44708
      • Cleveland, Ohio, United States, 44195
      • Mansfield, Ohio, United States, 44906
      • Toledo, Ohio, United States, 43623
    • 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, 19141
      • Philadelphia, Pennsylvania, United States, 19102
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78745
      • Dallas, Texas, United States, 75231
      • Fort Sam Houston, Texas, United States, 78234-6200
      • Tyler, Texas, United States, 75701
    • Utah
      • Layton, Utah, United States, 84041
    • Washington
      • Bellingham, Washington, United States, 98225
      • Burien, Washington, United States, 98166
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time 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
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
Time Frame: From randomization up to the date of the last dose of study drug + 2 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
Time 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
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.
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
Time 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
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.
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
Time 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
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.
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
Time 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
All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA 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 Non-central Nervous System Systemic Embolisms
Time 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
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.
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 Myocardial Infarctions
Time 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
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.
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 Cardiovascular Deaths
Time 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
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.
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 All-cause Mortality
Time 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
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.
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 Major and Non-major Bleeding Events
Time Frame: From randomization up to the date of the last dose of study drug + 2 days
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.
From randomization up to the date of the last dose of study drug + 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15693
  • 2011-002234-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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