search
Back to results

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)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban (Xarelto, BAY59-7939)
Vitamin K antagonist (VKA)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring rivaroxaban, oral anticoagulant, nonvalvular atrial fibrillation, cardioversion, stroke, transient ischemic attack, thromboembolism, cardiovascular event

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban (Xarelto, BAY59-7939)

Vitamin K antagonist (VKA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 27, 2012
Last Updated
April 10, 2015
Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01674647
Brief Title
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
Acronym
X-VERT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
rivaroxaban, oral anticoagulant, nonvalvular atrial fibrillation, cardioversion, stroke, transient ischemic attack, thromboembolism, cardiovascular event

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1504 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban (Xarelto, BAY59-7939)
Arm Type
Experimental
Arm Description
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.
Arm Title
Vitamin K antagonist (VKA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vitamin K antagonist (VKA)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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.
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
Title
Number of Participants With Major Bleedings as Per Central Adjudication
Description
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.
Time Frame
From randomization up to the date of the last dose of study drug + 2 days
Secondary Outcome Measure Information:
Title
Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
Description
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.
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
Title
Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality
Description
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.
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
Title
Number of Participants With Strokes
Description
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.
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
Title
Number of Participants With Transient Ischemic Attacks
Description
All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.
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
Title
Number of Participants With Non-central Nervous System Systemic Embolisms
Description
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.
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
Title
Number of Participants With Myocardial Infarctions
Description
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.
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
Title
Number of Participants With Cardiovascular Deaths
Description
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.
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
Title
Number of Participants With All-cause Mortality
Description
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.
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
Title
Number of Participants With Composite of Major and Non-major Bleeding Events
Description
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.
Time Frame
From randomization up to the date of the last dose of study drug + 2 days

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
25182247
Citation
Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.
Results Reference
background
PubMed Identifier
24944325
Citation
Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241. No abstract available.
Results Reference
background
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

We'll reach out to this number within 24 hrs