Clinical trial NCT00403767: An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Official title: A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Stroke
Embolism
Keywords: Atrial Fibrillation
Stroke
Embolism
Non-central nervous system systemic embolism
Non-valvular atrial fibrillation
Blood Clot
Rivaroxaban
Warfarin
Anticoagulants
Arrhythmias, Cardiac
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-11-27
Enrollment: 14269
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: The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Detailed description: Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.

Eligibility criteria: Inclusion Criteria:

* Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

Exclusion Criteria:

* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders

Primary outcomes:
measure: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
timeFrame: Up to 4 years
measure: The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
timeFrame: Up to 4 years
measure: The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
timeFrame: Up to 4 years
Secondary outcomes:
measure: The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
timeFrame: Up to 4 years
measure: The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
timeFrame: Up to 4 years
measure: The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
timeFrame: Up to 4 years
measure: The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
timeFrame: Up to 4 years
measure: The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
timeFrame: Up to 4 years
measure: The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
timeFrame: Up to 4 years
measure: All-cause Mortality
timeFrame: Up to 4 years
Other outcomes:
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city: Turku
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city: Albi
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city: Arras
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city: Belfort
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city: Besancon N/A
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city: Bourg En Bresse
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city: Brest
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city: Béziers Languedoc-Roussillon
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
city: Markkleeberg
country: Germany
city: Meißen
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
city: Witten
country: Germany
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country: Germany
city: Wuppertal
country: Germany
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country: Greece
city: Ioannina
country: Greece
city: Maroussi Athens
country: Greece
city: Patra
country: Greece
city: Piraeus Attica
country: Greece
city: Tripoli
country: Greece
city: Voula Attica
country: Greece
city: Aberdeen
country: Hong Kong
city: Hk
country: Hong Kong
city: Kln
country: Hong Kong
city: Sha Tin
country: Hong Kong
city: Budapest N/A
country: Hungary
city: Budapest Nap
country: Hungary
city: Budapest
country: Hungary
city: Debrecen County
country: Hungary
city: Eger
country: Hungary
city: Gyongyos
country: Hungary
city: Gyõr
country: Hungary
city: Kesckemet
country: Hungary
city: Miskolc
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
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city: Veszprem
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city: Bangalore
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country: India
city: Madurai
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country: India
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country: India
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city: Vishakapatnam
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country: Israel
city: Ashkelon
country: Israel
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country: Israel
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country: Israel
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country: Israel
city: Jerusalem
country: Israel
city: Nazareth
country: Israel
city: Netanya
country: Israel
city: Petach-Tikva
country: Israel
city: Petah-Tikva
country: Israel
city: Poriya
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Zerifin
country: Israel
city: Anyang
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Goyang
country: Korea, Republic of
city: Kyonggi-Do
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Sungnam
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
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city: Klaipeda
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city: Panevezys
country: Lithuania
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city: Kuala Lumpur
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city: Guadalajara
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city: Hermosillo
country: Mexico
city: Monterrey Nuevo Leòn
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city: Monterrey
country: Mexico
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city: San Luis Potosi
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city: Sinaloa
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city: Zapopan
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city: 'S-Gravenhage
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city: Alkmaar
country: Netherlands
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Blaricum
country: Netherlands
city: Delft
country: Netherlands
city: Den Bosch
country: Netherlands
city: Den Haag
country: Netherlands
city: Gc Tilburg
country: Netherlands
city: Gouda
country: Netherlands
city: Groningen
country: Netherlands
city: Haarlem
country: Netherlands
city: Heerlen
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Hoorn Nh
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Leidschendam
country: Netherlands
city: Maastricht
country: Netherlands
city: Meppel
country: Netherlands
city: Nijmegen
country: Netherlands
city: Schiedam
country: Netherlands
city: Veldhoven
country: Netherlands
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city: Bergen
country: Norway
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country: Norway
city: Hamar
country: Norway
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city: Moss
country: Norway
city: Oslo
country: Norway
city: Sandefjord
country: Norway
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country: Norway
city: Sandvika
country: Norway
city: Skedsmokorset
country: Norway
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city: Lima
country: Peru
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Changhua
country: Taiwan
city: Kaohsiung
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city: Taichung
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city: Tainan
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city: Taipei
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city: Tamshui
country: Taiwan
city: Tao-Yuan
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city: Bangkok Noi
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city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Pathumthani
country: Thailand
city: Phathumwan
country: Thailand
city: Ratchatewi
country: Thailand
city: Adana
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city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Aydin
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city: Denizli
country: Turkey
city: Diyarbakir
country: Turkey
city: Eskisehir
country: Turkey
city: Görükle
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmit
country: Turkey
city: Kayseri
country: Turkey
city: Konya
country: Turkey
city: Malatya Nap
country: Turkey
city: Mersin
country: Turkey
city: Samsun
country: Turkey
city: Cherkassy
country: Ukraine
city: Chernigiv
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkov
country: Ukraine
city: Kirovograd
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Lviv
country: Ukraine
city: O1103 Kyiv
country: Ukraine
city: Odesa
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopil
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsya
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zhytomyr
country: Ukraine
city: Aberdeen
country: United Kingdom
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Cambridgeshire
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Colchester
country: United Kingdom
city: Craigavon
country: United Kingdom
city: Devon
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrogate
country: United Kingdom
city: Hull
country: United Kingdom
city: Leicester
country: United Kingdom
city: Lincoln
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Romford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stirling
country: United Kingdom
city: Stoke On Trent
country: United Kingdom
city: York
country: United Kingdom
city: Caracas
country: Venezuela
city: Maracaibo Estado Zulia
country: Venezuela
city: Maracay Estado Aragua
country: Venezuela
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.
citation: Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.
citation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.
citation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.
citation: Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.
citation: Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.
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