Clinical trial NCT01674647: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: rivaroxaban
oral anticoagulant
nonvalvular atrial fibrillation
cardioversion
stroke
transient ischemic attack
thromboembolism
cardiovascular event
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-08-29
Enrollment: 1504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
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
timeFrame: 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
measure: Number of Participants With Major Bleedings as Per Central Adjudication
timeFrame: From randomization up to the date of the last dose of study drug + 2 days
Secondary outcomes:
measure: Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
timeFrame: 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
measure: Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality
timeFrame: 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
measure: Number of Participants With Strokes
timeFrame: 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
measure: Number of Participants With Transient Ischemic Attacks
timeFrame: 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
measure: Number of Participants With Non-central Nervous System Systemic Embolisms
timeFrame: 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
measure: Number of Participants With Myocardial Infarctions
timeFrame: 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
measure: Number of Participants With Cardiovascular Deaths
timeFrame: 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
measure: Number of Participants With All-cause Mortality
timeFrame: 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
measure: Number of Participants With Composite of Major and Non-major Bleeding Events
timeFrame: From randomization up to the date of the last dose of study drug + 2 days
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: East Palo Alto
country: United States
state: California
city: El Cajon
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state: California
city: National City
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state: California
city: Sacramento
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state: California
city: Santa Rosa
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state: California
city: Torrance
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state: California
city: New Haven
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state: Connecticut
city: Stamford
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state: Connecticut
city: Wilmington
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state: Delaware
city: Clearwater
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city: Daytona Beach
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city: Ft. Lauderdale
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city: Jacksonville
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city: Miami
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city: North Las Vegas
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state: Vlaams Brabant
city: Bruxelles - Brussel
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city: Gilly
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city: Hasselt
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city: Edmonton
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city: Vaasa
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city: Arras
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city: Lille Cedex
country: France
city: Paris cedex 13
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city: Pessac
country: France
city: TOULOUSE cedex
country: France
city: Tours
country: France
city: Vandoeuvre-les-nancy
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Nürnberg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Bad Oeynhausen
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Alexandroupolis
country: Greece
city: Attica / Athens
country: Greece
city: Heraklion
country: Greece
city: Thessaloniki
country: Greece
city: Acquaviva delle Fonti
country: Italy
state: Bari
city: San Fermo della Battaglia
country: Italy
state: Como
city: San Donato Milanese
country: Italy
state: Milano
city: Mestre
country: Italy
state: Venezia
city: Ancona
country: Italy
city: Catania
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Arnhem
country: Netherlands
city: Haarlem
country: Netherlands
city: Heerlen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Maastricht
country: Netherlands
city: Martinho do Bispo
country: Portugal
state: Coimbra
city: Carnaxide
country: Portugal
state: Lisboa
city: Almada
country: Portugal
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Vila Nova de Gaia
country: Portugal
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
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city: Singapore
country: Singapore
city: Alberton
country: South Africa
state: Gauteng
city: Soweto
country: South Africa
state: Gauteng
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Kuils River
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Bloemfontein
country: South Africa
city: Sabadell
country: Spain
state: Barcelona
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Bournemouth
country: United Kingdom
state: Dorset
city: Welwyn Garden City
country: United Kingdom
state: Hertfordshire
city: Leicester
country: United Kingdom
state: Leicestershire
city: Nottingham
country: United Kingdom
state: Nottinghamshire
city: Cliftonville
country: United Kingdom
city: London
country: United Kingdom
city: Portsmouth
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.
citation: Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241. No abstract available.