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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00403767
First received: November 23, 2006
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Stroke
Embolism
Drug: Rivaroxaban
Drug: Warfarin
Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment.


Secondary Outcome Measures:
  • The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment.

  • The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.

  • All-cause Mortality [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment.


Enrollment: 14269
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban Drug: Rivaroxaban
Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)
Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
Active Comparator: Warfarin Drug: Warfarin
Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years
Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403767

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Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Geneva, Alabama, United States
Mobile, Alabama, United States
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Halifax, Nova Scotia, Canada
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Henstedt-Rhen, Germany
Herford, Germany
Homburg/Saar, Germany
Jena, Germany
Julich, Germany
Kamen, Germany
Karlsbad, Germany
Kassel, Germany
Kirchzarten, Germany
Krefeld, Germany
Leipzig, Germany
Ludwigsburg, Germany
Ludwigshafen, Germany
Lüneburg, Germany
Magdeburg, Germany
Mainz, Germany
Mannheim, Germany
Markkleeberg, Germany
Meißen, Germany
Melsungen, Germany
Monchengladbach, Germany
Munchen, Germany
Mühldorf, Germany
Mülheim, Germany
Münster, Germany
Neuwied, Germany
Nienburg, Germany
Nuernberg, Germany
Paderborn, Germany
Potsdam, Germany
Riesa, Germany
Rottweil, Germany
Sachsen, Germany
Siegen, Germany
Ulm, Germany
Wermsdorf, Germany
Witten, Germany
Wolmirstedt, Germany
Wuppertal, Germany
Greece
Athens Attica, Greece
Ioannina, Greece
Maroussi Athens, Greece
Patra, Greece
Piraeus Attica, Greece
Tripoli, Greece
Voula Attica, Greece
Hong Kong
Aberdeen, Hong Kong
Hk, Hong Kong
Kln, Hong Kong
Sha Tin, Hong Kong
Hungary
Budapest, Hungary
Budapest N/A, Hungary
Budapest Nap, Hungary
Debrecen County, Hungary
Eger, Hungary
Gyongyos, Hungary
Gyõr, Hungary
Kesckemet, Hungary
Miskolc, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Szeged, Hungary
Szekszard, Hungary
Szombathely, Hungary
Veszprem, Hungary
Zalaegerszeg, Hungary
India
Ahmedabad, India
Bangalore, India
Bikaner, India
Chennai, India
Coimbatore, India
Gandhinagar Guiarat, India
Hyderabad, India
Hyderabad Andra Pradesh, India
Jalandhar, India
Madurai, India
Mangalore, India
Mumbai, India
Mysore, India
New Delhi, India
Pune, India
Suraj, India
Vadodara, India
Vishakapatnam, India
Israel
Afula, Israel
Ashkelon, Israel
Hadera, Israel
Haifa, Israel
Holon, Israel
Jerusalem, Israel
Nazareth, Israel
Netanya, Israel
Petach-Tikva, Israel
Petah-Tikva, Israel
Poriya, Israel
Rehovot, Israel
Safed, Israel
Tel Aviv, Israel
Tel Hashomer, Israel
Zerifin, Israel
Korea, Republic of
Anyang, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Goyang, Korea, Republic of
Kyonggi-Do, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Sungnam, Korea, Republic of
Suwon, Korea, Republic of
Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Panevezys, Lithuania
Siauliai, Lithuania
Vilnius, Lithuania
Malaysia
Kelantan, Malaysia
Kuala Lumpur, Malaysia
Sarawak, Malaysia
Mexico
Aguascalientes, Mexico
Ciudad De Mexico, Mexico
Culiacán Sinaloa/Mèxico, Mexico
Guadalajara, Mexico
Hermosillo, Mexico
Monterrey, Mexico
Monterrey Nuevo Leòn, Mexico
Queretaro, Mexico
San Luis Potosi, Mexico
Sinaloa, Mexico
Zapopan, Mexico
Netherlands
'S-Gravenhage, Netherlands
Alkmaar, Netherlands
Amersfoort, Netherlands
Amsterdam, Netherlands
Blaricum, Netherlands
Delft, Netherlands
Den Bosch, Netherlands
Den Haag, Netherlands
Gc Tilburg, Netherlands
Gouda, Netherlands
Groningen, Netherlands
Haarlem, Netherlands
Heerlen, Netherlands
Hoofddorp, Netherlands
Hoorn Nh, Netherlands
Leeuwarden, Netherlands
Leidschendam, Netherlands
Maastricht, Netherlands
Meppel, Netherlands
Nijmegen, Netherlands
Schiedam, Netherlands
Veldhoven, Netherlands
New Zealand
Christchurch, New Zealand
Dunedin, New Zealand
Grafton, New Zealand
Hamilton, New Zealand
Takapuna Auckland, New Zealand
Wellington, New Zealand
Norway
Alesund, Norway
Bergen, Norway
Elverum, Norway
Hamar, Norway
Jessheim, Norway
Lillehammer, Norway
Moss, Norway
Oslo, Norway
Sandefjord, Norway
Sandnes, Norway
Sandvika, Norway
Skedsmokorset, Norway
Peru
L41 Lima Lima, Peru
Lima, Peru
Lima 1 Lima Lima, Peru
Philippines
Cebuu City, Philippines
Davao City, Philippines
Iloilo City, Philippines
Manila City, Philippines
Quezon City, Philippines
Poland
Bydgoszcz, Poland
Bydgoszcz N/A, Poland
Gdansk, Poland
Gdynia, Poland
Katowice, Poland
Katowice-Ochojec, Poland
Krakow, Poland
Lodz, Poland
Olawa, Poland
Olsztyn, Poland
Opole, Poland
Ostrowiec N/A, Poland
Piotrkow Trybunalski, Poland
Plock, Poland
Poznan, Poland
Siedlce, Poland
Sieradz N/A, Poland
Skierniewice, Poland
Starogard Gdanski Nap, Poland
Szczecin, Poland
Szczecin Nap, Poland
Torun, Poland
Warsaw, Poland
Warszawa, Poland
Warszawa N/A, Poland
Wloclawek, Poland
Wroclaw, Poland
Wroclaw N/A, Poland
Zyrardow N/A, Poland
Romania
Brasov, Romania
Bucharest, Romania
Bucuresti, Romania
Craiova, Romania
Focsani, Romania
Iasi, Romania
Oradea, Romania
Sibiu, Romania
Suceava, Romania
Tg Mures, Romania
Timisoara, Romania
Russian Federation
Barnaul, Russian Federation
Chelyabinsk, Russian Federation
Chelyabinsk Chelyabinsk Region, Russian Federation
Ekaterinburg, Russian Federation
Kemerovo, Russian Federation
Krasnoyarsk, Russian Federation
Moscow, Russian Federation
Moscow N/A, Russian Federation
Nizhni Novgorod, Russian Federation
Novosibirsk, Russian Federation
Novosibirsk Nap, Russian Federation
Orenburg, Russian Federation
Perm, Russian Federation
Ryazan, Russian Federation
Saint Petersburg, Russian Federation
Saint-Petersburg, Russian Federation
Saratov, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
St. Petersburg, Russian Federation
Tomsk, Russian Federation
Tyumen Tyumen Region, Russian Federation
Yaroslavl, Russian Federation
Yaroslavl Nap, Russian Federation
Singapore
Singapore, Singapore
South Africa
Bloemfontein Free State, South Africa
Bloemfontein Orange Free State, South Africa
Cape Town, South Africa
Cape Town Western Cape, South Africa
Centurion Gauteng, South Africa
Durban Kwa Zulu Natal, South Africa
Johannesburg Gauteng, South Africa
Kempton Park Gauteng, South Africa
Port Elizabeth Eastern Cape, South Africa
Pretoria Gauteng, South Africa
Somerset West Western Cape, South Africa
Van Der Bijl Park, South Africa
Worcester Western Cape, South Africa
Spain
A Coruna, Spain
Alicante N/A, Spain
Almeria, Spain
Baracaldo Vizcaya, Spain
Barcelona, Spain
Burgos, Spain
Guadalajara, Spain
La Corona, Spain
Madrid, Spain
Malaga, Spain
Oviedo, Spain
Palma De Mallorca, Spain
Pamplona, Spain
Pontevedra, Spain
Sabadell, Spain
San Sebastián Guipúzcoa, Spain
Sevilla, Spain
Terrassa, Spain
Valencia, Spain
Valladolid, Spain
Sweden
Ljungby, Sweden
Lund, Sweden
Sala, Sweden
Skövde, Sweden
Uppsala, Sweden
Switzerland
Basel Bs, Switzerland
Bruderholz, Switzerland
Geneve, Switzerland
Zurich, Switzerland
Taiwan
Changhua, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Tamshui, Taiwan
Tao-Yuan, Taiwan
Thailand
Bangkok, Thailand
Bangkok Noi, Thailand
Chiang Mai, Thailand
Pathumthani, Thailand
Phathumwan, Thailand
Ratchatewi, Thailand
Turkey
Adana, Turkey
Ankara, Turkey
Antalya, Turkey
Aydin, Turkey
Denizli, Turkey
Diyarbakir, Turkey
Eskisehir, Turkey
Görükle, Turkey
Istanbul, Turkey
Izmir, Turkey
Izmit, Turkey
Kayseri, Turkey
Konya, Turkey
Malatya Nap, Turkey
Mersin, Turkey
Samsun, Turkey
Ukraine
Cherkassy, Ukraine
Chernigiv, Ukraine
Dnepropetrovsk, Ukraine
Dnipropetrovsk, Ukraine
Donetsk, Ukraine
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kharkov, Ukraine
Kirovograd, Ukraine
Kyiv, Ukraine
Lugansk, Ukraine
Lviv, Ukraine
O1103 Kyiv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Simferopil, Ukraine
Sumy, Ukraine
Ternopil, Ukraine
Uzhgorod, Ukraine
Vinnitsya, Ukraine
Vinnytsia, Ukraine
Zaporizhzhya, Ukraine
Zhytomyr, Ukraine
United Kingdom
Aberdeen, United Kingdom
Belfast, United Kingdom
Birmingham, United Kingdom
Bournemouth, United Kingdom
Cambridgeshire, United Kingdom
Chelmsford, United Kingdom
Chesterfield, United Kingdom
Colchester, United Kingdom
Craigavon, United Kingdom
Devon, United Kingdom
Dundee, United Kingdom
Glasgow, United Kingdom
Harrogate, United Kingdom
Hull, United Kingdom
Leicester, United Kingdom
Lincoln, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Plymouth, United Kingdom
Romford, United Kingdom
Sheffield, United Kingdom
Stirling, United Kingdom
Stoke On Trent, United Kingdom
York, United Kingdom
Venezuela
Caracas, Venezuela
Maracaibo Estado Zulia, Venezuela
Maracay Estado Aragua, Venezuela
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bayer
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00403767     History of Changes
Other Study ID Numbers: CR012157, 39039039AFL3001, ROCKET AF, 2006-004595-13
Study First Received: November 23, 2006
Results First Received: December 2, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Atrial Fibrillation
Stroke
Embolism
Non-central nervous system systemic embolism
Non-valvular atrial fibrillation
Blood Clot
Rivaroxaban
Warfarin
Anticoagulants
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia
Rivaroxaban
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014