A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following Hospitalization for Heart Failure (COMMANDER HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01877915
First received: June 12, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with chronic heart failure and significant coronary artery disease following a recent hospitalization for exacerbation (worsening) of heart failure.


Condition Intervention Phase
Heart Failure
Coronary Artery Disease
Drug: Rivaroxaban
Drug: Placebo
Other: Standard of care for heart failure and coronary artery disease
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: Treatment
Official Title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Time to the first occurrence of any of the following: death from any cause, myocardial infarction, or stroke [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: No ]
  • Time to the first occurrence of either fatal bleeding or bleeding into a critical space with potential for permanent disability [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to the first occurrence of either death due to a cardiovascular cause or re-hospitalization for worsening of heart failure [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: No ]
    If both events occur (re-hospitalization and death) they will be separately counted as per outcome measures below.

  • Time to death due to a cardiovascular cause [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: No ]
  • Time to rehospitalization for worsening of heart failure [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: No ]
  • Time to rehospitalization for cardiovascular events [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: No ]
  • Time to bleeding requiring hospitalization [ Time Frame: Day 1 up to approximately Month 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: September 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban 2.5 mg
Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Drug: Rivaroxaban
Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 984 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Other: Standard of care for heart failure and coronary artery disease
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
Placebo Comparator: Placebo
Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Drug: Placebo
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Other: Standard of care for heart failure and coronary artery disease
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.

Detailed Description:

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with chronic heart failure and significant coronary artery disease following hospitalization (an overnight stay in a hospital, emergency department, or medical facility with the capability of treating heart failure with intravenous medications) for exacerbation of heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 984 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 30 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit between 15 and 45 days (but no sooner than 15 days) after the GTED. Patient safety will be monitored throughout the study. The study duration for each participant is expected to be approximately 16 months. The study drug, rivaroxaban, is approved in the United States and in several countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have documented symptomatic chronic heart failure for at least 3 months prior to screening and must hospitalized for exacerbation of chronic heart failure (index hospitalization
  • participant must have a minimum of an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization) before randomization
  • Must have a documented left ventricular ejection fraction of less than or equal to 40% within 1 year before randomization
  • Must have evidence of significant coronary artery disease
  • Must be medically stable in terms of heart failure clinical status at the time of randomization
  • Must also have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL

Exclusion Criteria:

  • Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding at anytime from hospitalization through randomization
  • Severe concomitant disease or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
  • Prior stroke within 90 days of randomization
  • Has been hospitalized for longer than 21 days during the index hospitalization
  • Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
  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: NCT01877915

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Alabama
Not yet recruiting
Birmingham, Alabama, United States
Withdrawn
Huntsville, Alabama, United States
Recruiting
Mobile, Alabama, United States
United States, Arizona
Not yet recruiting
Avondale, Arizona, United States
Withdrawn
Phoenix, Arizona, United States
United States, Arkansas
Withdrawn
Fort Smith, Arkansas, United States
Recruiting
Jonesboro, Arkansas, United States
United States, California
Withdrawn
Carmichael, California, United States
Withdrawn
Inglewood, California, United States
Withdrawn
Sacramento, California, United States
Withdrawn
Stockton, California, United States
Not yet recruiting
Stockton, California, United States
Not yet recruiting
Torrance, California, United States
Recruiting
Torrance, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
Not yet recruiting
Denver, Colorado, United States
United States, Connecticut
Withdrawn
Guilford, Connecticut, United States
United States, Florida
Completed
Daytona Beach, Florida, United States
Withdrawn
Fort Lauderdale, Florida, United States
Withdrawn
Melbourne, Florida, United States
Recruiting
St. Petersburg, Florida, United States
Recruiting
Winter Haven, Florida, United States
United States, Georgia
Not yet recruiting
Athens, Georgia, United States
Withdrawn
Atlanta, Georgia, United States
Not yet recruiting
Atlanta, Georgia, United States
Withdrawn
Augusta, Georgia, United States
Withdrawn
Columbus, Georgia, United States
Recruiting
Cumming, Georgia, United States
Recruiting
Macon, Georgia, United States
Recruiting
Tucker, Georgia, United States
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States
Not yet recruiting
Evanston, Illinois, United States
Not yet recruiting
Hazel Crest, Illinois, United States
Withdrawn
Maywood, Illinois, United States
Recruiting
Peoria, Illinois, United States
Recruiting
Rockford, Illinois, United States
United States, Indiana
Withdrawn
Indianapolis, Indiana, United States
Recruiting
Indianapolis, Indiana, United States
Recruiting
Merrillville, Indiana, United States
Recruiting
South Bend, Indiana, United States
United States, Iowa
Not yet recruiting
Iowa City, Iowa, United States
United States, Kentucky
Recruiting
Elizabethtown, Kentucky, United States
Recruiting
Louisvile, Kentucky, United States
Recruiting
Owensboro, Kentucky, United States
United States, Louisiana
Recruiting
Slidell, Louisiana, United States
United States, Maine
Withdrawn
Auburn, Maine, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
Not yet recruiting
Randallstown, Maryland, United States
United States, Michigan
Withdrawn
Detroit, Michigan, United States
Recruiting
Pontiac, Michigan, United States
United States, Missouri
Not yet recruiting
Saint Louis, Missouri, United States
Not yet recruiting
St. Louis, Missouri, United States
United States, Nebraska
Withdrawn
Lincoln, Nebraska, United States
Withdrawn
Omaha, Nebraska, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New Jersey
Recruiting
Bridgewater, New Jersey, United States
Not yet recruiting
Bridgewater, New Jersey, United States
Withdrawn
Elmer, New Jersey, United States
Recruiting
Manalapan, New Jersey, United States
Withdrawn
Newark, New Jersey, United States
Recruiting
Ridgewood, New Jersey, United States
United States, New Mexico
Not yet recruiting
Albuquerque, New Mexico, United States
United States, New York
Recruiting
Buffalo, New York, United States
Recruiting
Corlandt Manor, New York, United States
Not yet recruiting
Jamaica, New York, United States
Recruiting
New York, New York, United States
Withdrawn
Saratoga Springs, New York, United States
Withdrawn
Stony Brook, New York, United States
Withdrawn
Syracuse, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
Withdrawn
Greensboro, North Carolina, United States
Recruiting
High Point, North Carolina, United States
United States, Ohio
Withdrawn
Akron, Ohio, United States
Recruiting
Canton, Ohio, United States
Not yet recruiting
Cincinnati, Ohio, United States
Withdrawn
Cincinnatti, Ohio, United States
Recruiting
Dayton, Ohio, United States
Recruiting
Fairfield, Ohio, United States
Withdrawn
Mansfield, Ohio, United States
United States, Oklahoma
Recruiting
Bartlesville, Oklahoma, United States
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Withdrawn
Portland, Oregon, United States
United States, Pennsylvania
Withdrawn
Camp Hill, Pennsylvania, United States
Withdrawn
Lancaster, Pennsylvania, United States
Not yet recruiting
Philadelphia, Pennsylvania, United States
Withdrawn
Pittsburgh, Pennsylvania, United States
Recruiting
Sayre, Pennsylvania, United States
Recruiting
Wynnewood, Pennsylvania, United States
Recruiting
York, Pennsylvania, United States
United States, South Dakota
Withdrawn
Rapid City, South Dakota, United States
Not yet recruiting
Sioux Falls, South Dakota, United States
United States, Tennessee
Withdrawn
Jackson, Tennessee, United States
Withdrawn
Knoxville, Tennessee, United States
United States, Texas
Not yet recruiting
Fort Worth, Texas, United States
Withdrawn
Galveston, Texas, United States
Not yet recruiting
Kingwood, Texas, United States
Not yet recruiting
Mckinney, Texas, United States
Withdrawn
Mission, Texas, United States
Withdrawn
San Antonio, Texas, United States
United States, Utah
Withdrawn
Salt Lake City, Utah, United States
United States, Vermont
Recruiting
Burlington, Vermont, United States
United States, Virginia
Withdrawn
Danville, Virginia, United States
Withdrawn
Manassas, Virginia, United States
Withdrawn
Richmond, Virginia, United States
United States, Washington
Not yet recruiting
Spokane, Washington, United States
United States, Wisconsin
Withdrawn
Milwaukee, Wisconsin, United States
Argentina
Recruiting
Bahia Blanca, Argentina
Recruiting
Buenos Aires, Argentina
Suspended
Buenos Aires, Argentina
Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Ciudad Autonoma De Buenos Aires, Argentina
Not yet recruiting
Cordoba, Argentina
Recruiting
Cordoba, Argentina
Recruiting
Cordoba Capital, Argentina
Suspended
Coronel Suarez, Argentina
Suspended
Córdoba, Argentina
Recruiting
Córdoba, Argentina
Recruiting
Esperanza, Argentina
Recruiting
La Plata, Argentina
Recruiting
Mar Del Plata, Argentina
Recruiting
Merlo, Argentina
Suspended
Moron, Argentina
Recruiting
Rosario, Argentina
Recruiting
Santa Fe, Argentina
Recruiting
Tucuman, Argentina
Recruiting
Vicente Lopez, Argentina
Recruiting
Zarate, Buenos Aires, Argentina
Bulgaria
Recruiting
Burgas, Bulgaria
Not yet recruiting
Kazanlak, Bulgaria
Recruiting
Pazardzhik, Bulgaria
Recruiting
Pleven, Bulgaria
Recruiting
Plovdiv, Bulgaria
Recruiting
Rousse, Bulgaria
Recruiting
Sofia, Bulgaria
Completed
Sofia, Bulgaria
Not yet recruiting
Varna, Bulgaria
Recruiting
Veliko Tarnovo, Bulgaria
Canada, Alberta
Withdrawn
Edmonton, Alberta, Canada
Canada, British Columbia
Recruiting
Maple Ridge, British Columbia, Canada
Withdrawn
Penticton, British Columbia, Canada
Canada, Newfoundland and Labrador
Not yet recruiting
St. John'S, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Not yet recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Not yet recruiting
Cambridge, Ontario, Canada
Not yet recruiting
Kitchener, Ontario, Canada
Not yet recruiting
London, Ontario, Canada
Not yet recruiting
Ottawa, Ontario, Canada
Not yet recruiting
Scarborough, Ontario, Canada
Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
Withdrawn
Laval, Quebec, Canada
Not yet recruiting
Montreal, Quebec, Canada
Withdrawn
Montreal, Quebec, Canada
Withdrawn
Ste-Foy, Quebec, Canada
Canada
Not yet recruiting
Edmonton, Canada
Not yet recruiting
Montreal, Canada
Withdrawn
Red Deer, Canada
Withdrawn
St-Georges, Canada
China
Not yet recruiting
Beijing, China
Not yet recruiting
Changsha, China
Not yet recruiting
Daqing, China
Not yet recruiting
Guangzhou, China
Recruiting
Hangzhou, China
Not yet recruiting
Hangzhou, China
Withdrawn
Hangzhou, China
Withdrawn
Harbin, China
Not yet recruiting
Harbin, China
Not yet recruiting
Jinan, China
Not yet recruiting
Nanjing, China
Withdrawn
Shanghai, China
Not yet recruiting
Shanghai, China
Not yet recruiting
Shenyang, China
Withdrawn
Suzhou, China
Not yet recruiting
Suzhou, China
Withdrawn
Tianjin, China
Recruiting
Tianjin, China
Not yet recruiting
Wuhan, China
Not yet recruiting
Xi-An, China
Czech Republic
Recruiting
Brno, Czech Republic
Recruiting
Hodonin, Czech Republic
Recruiting
Hradec Kralove, Czech Republic
Recruiting
Hranice, Czech Republic
Recruiting
Karlovy Vary, Czech Republic
Recruiting
Kladno, Czech Republic
Recruiting
Kolin N/A, Czech Republic
Withdrawn
Liberec, Czech Republic
Recruiting
Litomysl, Czech Republic
Recruiting
Mlada Boleslav, Czech Republic
Recruiting
Olomouc, Czech Republic
Recruiting
Plzen, Czech Republic
Recruiting
Praha, Czech Republic
Withdrawn
Praha, Czech Republic
Recruiting
Praha 10 N/A, Czech Republic
Recruiting
Teplice, Czech Republic
Recruiting
Uherské Hradistì 6, Czech Republic
Recruiting
Valasske Mezirici N/A, Czech Republic
Germany
Recruiting
Berlin, Germany
Withdrawn
Berlin, Germany
Recruiting
Bonn, Germany
Withdrawn
Bremen, Germany
Recruiting
Dresden, Germany
Withdrawn
Düsseldorf, Germany
Withdrawn
Essen, Germany
Withdrawn
Frankfurt, He, Germany
Withdrawn
Greifswald, Germany
Recruiting
Halle (Saale), Germany
Recruiting
Hamburg, Germany
Recruiting
Heidelberg, Germany
Withdrawn
Jena, Germany
Withdrawn
Köln, Germany
Recruiting
Langen, Germany
Recruiting
Leipzig, Germany
Withdrawn
Limburg, Germany
Recruiting
Ludwigshafen, Germany
Withdrawn
Lübeck, Germany
Recruiting
Magdeburg, Germany
Recruiting
Mainz, Germany
Withdrawn
Mannheim, Germany
Withdrawn
Stuttgart, Germany
Recruiting
Stuttgart, Germany
Recruiting
Ulm, Germany
Recruiting
Witten, Germany
Hungary
Recruiting
Balatonfured, Hungary
Recruiting
Berettyóújfalú, Hungary
Withdrawn
Budapest, Hungary
Recruiting
Budapest, Hungary
Recruiting
Budapest N/A, Hungary
Withdrawn
Debrecen, Hungary
Recruiting
Gyõr, Hungary
Recruiting
Miskolc, Hungary
Recruiting
Nagykanizsa, Hungary
Recruiting
Szekesfehervar, Hungary
Recruiting
Szolnok, Hungary
Recruiting
Zalaegerszeg, Hungary
Japan
Recruiting
Kumamoto, Japan
Mexico
Withdrawn
Acapulco, Mexico
Withdrawn
Aguascalienes, Mexico
Recruiting
Aguascalientes, Mexico
Not yet recruiting
Benito Juárez, Mexico
Recruiting
Chihuahua, Mexico
Withdrawn
Ciudad De Mexico, Mexico
Recruiting
Culiacan, Mexico
Not yet recruiting
Durango, Mexico
Not yet recruiting
Guadalajara, Mexico
Withdrawn
Guadalajara, Mexico
Recruiting
Guadalajara, Mexico
Not yet recruiting
Gustavo A. Madero, Mexico
Not yet recruiting
Leon, Mexico
Withdrawn
Merida, Mexico
Not yet recruiting
Mexico, Mexico
Withdrawn
Mexico City, Mexico
Withdrawn
Monterrey, Mexico
Recruiting
Oaxaca, Mexico
Not yet recruiting
Queretaro, Mexico
Not yet recruiting
San Luis Potosi, Mexico
Recruiting
San Luis Potosi, Mexico
Recruiting
Tampico, Mexico
Recruiting
Veracruz, Mexico
Not yet recruiting
Zapopan, Mexico
Netherlands
Withdrawn
Alkmaar, Netherlands
Recruiting
Almere, Netherlands
Withdrawn
Amsterdam, Netherlands
Recruiting
Amsterdam, Netherlands
Recruiting
Blaricum, Netherlands
Recruiting
Breda, Netherlands
Recruiting
Deventer, Netherlands
Recruiting
Doetinchem, Netherlands
Recruiting
Ede Gld, Netherlands
Recruiting
Groningen, Netherlands
Withdrawn
Haarlem, Netherlands
Recruiting
Heerlen, Netherlands
Recruiting
Helmond, Netherlands
Recruiting
Meppel, Netherlands
Withdrawn
Rotterdam, Netherlands
Withdrawn
Tiel, Netherlands
Recruiting
Tilburg, Netherlands
Not yet recruiting
Zoetermeer, Netherlands
Withdrawn
Zutphen, Netherlands
Poland
Recruiting
Bedzin, Poland
Completed
Gdynia, Poland
Recruiting
Gdynia, Poland
Recruiting
Gliwice, Poland
Recruiting
Grodzisk Mazowiecki, Poland
Recruiting
Inowroclaw, Poland
Recruiting
Katowice, Poland
Recruiting
Katowice N/A, Poland
Recruiting
Krakow, Poland
Recruiting
Krakow Poland, Poland
Recruiting
Kraków, Poland
Recruiting
Kutno, Poland
Recruiting
Lodz, Poland
Not yet recruiting
Lublin, Poland
Recruiting
Nowy Targ, Poland
Recruiting
Ostrowiec Swietokrzyski, Poland
Recruiting
Oświęcim, Poland
Withdrawn
Piotrkow Trybunalski, Poland
Recruiting
Plock, Poland
Withdrawn
Poznan, Poland
Withdrawn
Pruszków, Poland
Recruiting
Pulawy, Poland
Recruiting
Rabka-Zdroj, Poland
Recruiting
Skierniewice, Poland
Recruiting
Starogard Gdanski, Poland
Recruiting
Szczecin, Poland
Withdrawn
Tarnów, Poland
Recruiting
Torun, Poland
Recruiting
Warszawa, Poland
Withdrawn
Warszawa, Poland
Not yet recruiting
Warzawa, Poland
Recruiting
Wloclawek, Poland
Recruiting
Wrocław, Poland
Recruiting
Zamosc, Poland
Recruiting
Łódż, Poland
Romania
Recruiting
Braila, Romania
Recruiting
Bucharest, Romania
Recruiting
Bucuresti, Romania
Recruiting
Craiova, Romania
Recruiting
Focsani, Romania
Recruiting
Oradea, Romania
Recruiting
Pitesti, Romania
Recruiting
Sibiu, Romania
Recruiting
Targu-Mures, Romania
Withdrawn
Timisoara, Romania
Recruiting
Timisoara, Romania
Russian Federation
Recruiting
Arkhangelsk, Russian Federation
Withdrawn
Barnaul, Russian Federation
Recruiting
Barnaul, Russian Federation
Recruiting
Chita, Russian Federation
Completed
Ekaterinburg, Russian Federation
Recruiting
Ekaterinburg, Russian Federation
Recruiting
Kemerovo, Russian Federation
Recruiting
Kirov, Russian Federation
Recruiting
Kursk, Russian Federation
Recruiting
Moscow, Russian Federation
Withdrawn
Moscow, Russian Federation
Withdrawn
Moscow N/A, Russian Federation
Recruiting
Nizhny Novgorod, Russian Federation
Withdrawn
Nizhny Novgorod, Russian Federation
Withdrawn
Omsk, Russian Federation
Withdrawn
Penza, Russian Federation
Recruiting
Pushkin, Saint-Petersburg, Russian Federation
Recruiting
Rostov On Don, Russian Federation
Recruiting
Rostov-On-Don, Russian Federation
Recruiting
Russia, Russian Federation
Recruiting
Ryazan, Russian Federation
Withdrawn
Saint Petersburg, Russian Federation
Recruiting
Saint Petersburg, Russian Federation
Recruiting
Saint-Petersburg, Russian Federation
Recruiting
Samara, Russian Federation
Recruiting
Saratov, Russian Federation
Recruiting
St Petersburg, Russian Federation
Recruiting
Syktyvkar, Russian Federation
Recruiting
Tomsk, Russian Federation
Withdrawn
Tomsk, Russian Federation
Recruiting
Tyumen, Russian Federation
Recruiting
Voronezh, Russian Federation
Spain
Recruiting
A Coruna, Spain
Recruiting
Alicante, Spain
Recruiting
Almeria, Spain
Recruiting
Avila, Spain
Withdrawn
Barcelona, Spain
Recruiting
Barcelona, Spain
Completed
Burgos, Spain
Recruiting
Fuenlabrada, Spain
Not yet recruiting
Granada, Spain
Recruiting
Madrid, Spain
Not yet recruiting
Madrid, Spain
Recruiting
Murcia, Spain
Recruiting
Palma De Mallorca, Spain
Withdrawn
Palma De Mallorca, Spain
Recruiting
Santander N/A, Spain
Withdrawn
Sevilla, Spain
Withdrawn
Valencia, Spain
Recruiting
Valencia, Spain
Not yet recruiting
Valencia, Spain
Withdrawn
Vigo, Spain
Recruiting
Viladecans, Spain
Ukraine
Recruiting
Cherkassy, Ukraine
Not yet recruiting
Dnipropetrovsk, Ukraine
Recruiting
Donetsk, Ukraine
Recruiting
Kharkiv, Ukraine
Completed
Kharkiv, Ukraine
Recruiting
Kharkov, Ukraine
Recruiting
Kiev, Ukraine
Recruiting
Kyiv, Ukraine
Not yet recruiting
Kyiv, Ukraine
Recruiting
Lutsk, Ukraine
Recruiting
Lviv, Ukraine
Not yet recruiting
Odesa, Ukraine
Not yet recruiting
Poltava, Ukraine
Recruiting
Sumy, Ukraine
Recruiting
Vinnitsa, Ukraine
Recruiting
Vinnytsia, Ukraine
Recruiting
Zaporizhzhia, Ukraine
Recruiting
Zaporizhzhya, Ukraine
Recruiting
Zytomir, Ukraine
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01877915     History of Changes
Other Study ID Numbers: CR101940, RIVAROXHFA3001, 2013-000046-19
Study First Received: June 12, 2013
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Germany: Ethics Commission
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Janssen Research & Development, LLC:
Rivaroxaban
Heart Failure
Coronary Artery Disease
Stroke
Myocardial Infarction
Anticoagulation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Infarction
Myocardial Infarction
Stroke
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014