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Atrial FibrillationPhase 3X-VERTNCT01674647

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

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonist (VKA) in people with Atrial Fibrillation, run by Bayer at 178 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonist (VKA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,504 participants
Where
178 sitesin 17 countries
Study dates
Oct 2012to Jan 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

178 sites in 17 countries.

178 sites in 17 countries

United States66 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Asheville, North Carolina, 28805

  • Study site

    Aurora, Illinois, 60504

  • Study site

    Austin, Texas, 78745

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bellingham, Washington, 98225

  • Study site

    Bridgewater, New Jersey, 08807

  • Study site

    Buffalo, New York, 14215

  • Study site

    Burien, Washington, 98166

  • Study site

    Butler, Pennsylvania, 16001

  • Study site

    Cantan, Ohio, 44708

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, Maryland, 21044

  • Study site

    Dallas, Texas, 75231

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Deltona, Florida, 32725

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    East Palo Alto, California, 94303

  • Study site

    El Cajon, California, 92020

  • Study site

    Elk Grove Village, Illinois, 60007

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fort Sam Houston, Texas, 78234-6200

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Lakeland, Florida, 33805

  • Study site

    Layton, Utah, 84041

  • Study site

    Lincoln, Nebraska, 68516

  • Study site

    Manalapan, New Jersey, 07716

  • Study site

    Mansfield, Ohio, 44906

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Miami, Florida, 33135

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    National City, California, 91950

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New York, New York, 10013

  • Study site

    New York, New York, 10032

  • Study site

    North Las Vegas, Nevada, 89086

  • Study site

    Orlando, Florida, 32806

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Rockford, Illinois, 61107

  • Study site

    Rockville, Maryland, 20853

  • Study site

    Sacramento, California, 95819

  • Study site

    Saint Augustine, Florida, 32216

  • Study site

    Santa Rosa, California, 95494

  • Study site

    Savannah, Georgia, 31419

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Stamford, Connecticut, 06905

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Torrance, California, 90502-2004

  • Study site

    Troy, New York, 12180

  • Study site

    Tyler, Texas, 75701

  • Study site

    Wausau, Wisconsin, 54401

  • Study site

    Wilmington, Delaware, 19803

Other trials in United States

Germany11 sites

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Berlin, State of Berlin, 13353

  • Study site

    Dresden, Saxony, 01067

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Leipzig, Saxony, 04289

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Study site

    Nuremberg, Bavaria, 90471

Other trials in Germany

China10 sites

  • Study site

    Beijing, 100029

  • Study site

    Changchun, Jilin

  • Study site

    Changsha, Hunan, 410011

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Nanchang, Jiangxi, 330006

  • Study site

    Shanghai, 200080

  • Study site

    Shenyang

  • Study site

    Ürümqi, Xinjiang

  • Study site

    Wuhan, Hubei

  • Study site

    Xi'an, Shaanxi, 710061

Other trials in China

Canada9 sites

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Québec, Quebec, G1V 4G5

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    Toronto, Ontario, M5B 1W8

  • Study site

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Finland9 sites

  • Study site

    Helsinki, FIN-00260

  • Study site

    Jyväskylä, 40620

  • Study site

    Lappeenranta

  • Study site

    Oulu

  • Study site

    Pori, 28500

  • Study site

    Rovaniemi, 96101

  • Study site

    Tampere, FIN-33520

  • Study site

    Turku, 20521

  • Study site

    Vaasa, 65130

Other trials in Finland

France9 sites

  • Study site

    Arras, 62000

  • Study site

    Lille, 59037

  • Study site

    Paris, 75012

  • Study site

    Paris, 75013

  • Study site

    Paris, 75018

  • Study site

    Pessac, 33604

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

  • Study site

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy8 sites

  • Study site

    Acquaviva delle Fonti, Bari, 70021

  • Study site

    Ancona, 60126

  • Study site

    Catania, 95126

  • Study site

    Mestre, Venezia, 30174

  • Study site

    Roma, 00169

  • Study site

    San Donato Milanese, Milano, 20097

  • Study site

    San Fermo della Battaglia, Como, 22020

  • Study site

    Torino, 10126

Other trials in Italy

South Africa8 sites

  • Study site

    Alberton, Gauteng, 1449

  • Study site

    Bloemfontein, 9301

  • Study site

    Cape Town, Western Cape, 7450

  • Study site

    Cape Town, Western Cape, 7505

  • Study site

    Kuils River, Western Cape, 7580

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Soweto, Gauteng, 2013

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

United Kingdom8 sites

  • Study site

    Bournemouth, Dorset, BH7 7DW

  • Study site

    Chesterfield, Derbyshire, S44 5BL

  • Study site

    Cliftonville, NN1 5BD

  • Study site

    Leicester, Leicestershire, LE3 9QP

  • Study site

    London, SW17 0RE

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Portsmouth, PO6 3LY

  • Study site

    Welwyn Garden City, Hertfordshire, AL7 4HQ

Other trials in United Kingdom

Belgium6 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Gilly, 6060

  • Study site

    Hasselt, 3500

  • Study site

    Leuven, Vlaams Brabant, 3000

  • Study site

    Liège, 4000

  • Study site

    Mol, 2400

Other trials in Belgium

Portugal6 sites

  • Study site

    Almada, 2801-951

  • Study site

    Carnaxide, Lisbon District, 2795-53

  • Study site

    Faro, Faro District, 8000-386

  • Study site

    Lisbon, 1169-024

  • Study site

    Martinho Do Bispo, Coimbra District, 3041-801

  • Study site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Spain6 sites

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Granada, Granada, 18012

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Pamplona, Pamplona, 31008

  • Study site

    Sabadell, Barcelona, 08208

Other trials in Spain

Brazil5 sites

  • Study site

    Campinas, São Paulo, 13010-001

  • Study site

    Campinas, São Paulo, 13060904

  • Study site

    Curitiba, Paraná, 80730-150

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

Netherlands5 sites

  • Study site

    Arnhem, 6815 AD

  • Study site

    Haarlem, 2035 RC

  • Study site

    Heerlen, 6419 PC

  • Study site

    Leeuwarden, 8934 AD

  • Study site

    Maastricht, 6229 HX

Other trials in Netherlands

Denmark4 sites

  • Study site

    Hellerup, 2900

  • Study site

    Herning, 7400

  • Study site

    København NV, 2400

  • Study site

    Viborg, 8800

Other trials in Denmark

Greece4 sites

  • Study site

    Alexandroupoli, 68100

  • Study site

    Attica / Athens, 11526

  • Study site

    Heraklion, 711 10

  • Study site

    Thessaloniki, 54642

Other trials in Greece

Singapore4 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 168752

  • Study site

    Singapore, 308433

  • Study site

    Singapore, 768828

Other trials in Singapore

About this study

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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
Keywords
rivaroxaban, oral anticoagulant, nonvalvular atrial fibrillation, cardioversion, stroke, transient ischemic attack, thromboembolism, cardiovascular event
Medical subject headings
Atrial Fibrillation, Stroke, Ischemic Attack, Transient, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    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

  • Vitamin K antagonist (VKA)Drug

    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

Study groups in NCT01674647
Study groupRoleWhat they receive
Rivaroxaban (Xarelto, BAY59-7939)ExperimentalA 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.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Vitamin K antagonist (VKA)Active comparatorA 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.
Receives: Drug: Vitamin K antagonist (VKA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: From randomization up to the date of the last dose of study drug + 2 days

Secondary outcomes (9)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

    Measured: 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

  8. 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.

    Measured: 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

  9. 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.

    Measured: From randomization up to the date of the last dose of study drug + 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674647
Sponsor's protocol ID
15693
Other IDs
2011-002234-39
Acronym
X-VERT
Status last verified
Apr 2015
First submitted
27 Aug 2012
Last updated
30 Apr 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25182247

  • Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241. No abstract available.

    PubMed 24944325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonist (VKA) in people with Atrial Fibrillation, run by Bayer at 178 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Germany, China, Canada, Finland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01674647, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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