Last updated on March 2018

A clinical trial to evaluate treatments for patients with Coronary Artery Disease, Heart failure, Coronary heart disease


Brief description of study

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 heart failure and significant coronary artery disease following an episode of decompensated heart failure.

Detailed Study 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 heart failure and significant coronary artery disease following an episode of decompensated 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 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 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 average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.

Clinical Study Identifier: NCT01877915

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Aurora, CO United States

Atlanta, GA United States

Biddeford, ME United States

Alexander City, AL United States

Birmingham, AL United States

Mobile, AL United States

Anchorage, AK United States

Tucson, AZ United States

Jonesboro, AR United States

Beverly Hills, CA United States

Chula Vista, CA United States

El Cajon, CA United States

Glendale, CA United States

La Mesa, CA United States

Los Angeles, CA United States

Newport Beach, CA United States

Orange, CA United States

Stockton, CA United States

Torrance, CA United States

Denver, CO United States

New Haven, CT United States

Atlantis, FL United States

Daytona Beach, FL United States

Jupiter, FL United States

Orlando, FL United States

Saint Petersburg, FL United States

Tallahassee, FL United States

Wellington, FL United States

Winter Haven, FL United States

Athens, GA United States

Cumming, GA United States

Macon, GA United States

Tucker, GA United States

Chicago, IL United States

Evanston, IL United States

Fairview Heights, IL United States

Peoria, IL United States

Rockford, IL United States

Urbana, IL United States

Anderson, IN United States

Indianapolis, IN United States

Merrillville, IN United States

Munster, IN United States

South Bend, IN United States

Iowa City, IA United States

Elizabethtown, KY United States

Lexington, KY United States

Louisville, KY United States

Owensboro, KY United States

Bossier City, LA United States

Hammond, LA United States

Shreveport, LA United States

Slidell, LA United States

Baltimore, MD United States

Columbia, MD United States

Randallstown, MD United States

Bay City, MI United States

Grand Blanc, MI United States

Mount Clemens, MI United States

Pontiac, MI United States

Ypsilanti, MI United States

Saint Paul, MN United States

Saint Louis, MO United States

Springfield, MO United States

Washington, MO United States

Lincoln, NE United States

Las Vegas, NV United States

Bridgewater, NJ United States

Elmer, NJ United States

Haddon Heights, NJ United States

Manalapan, NJ United States

Ridgewood, NJ United States

Sewell, NJ United States

Albuquerque, NM United States

Buffalo, NY United States

Cortlandt Manor, NY United States

Jamaica, NY United States

Mineola, NY United States

New York, NY United States

Charlotte, NC United States

High Point, NC United States

Pinehurst, NC United States

Canton, OH United States

Cincinnati, OH United States

Columbus, OH United States

Dayton, OH United States

Fairfield, OH United States

Kettering, OH United States

Bartlesville, OK United States

Oklahoma City, OK United States

Tulsa, OK United States

Portland, OR United States

Doylestown, PA United States

Philadelphia, PA United States

Sayre, PA United States

Sellersville, PA United States

Wynnewood, PA United States

Yardley, PA United States

York, PA United States

Charleston, SC United States

Sioux Falls, SD United States

Nashville, TN United States

Cypress, TX United States

Dallas, TX United States

Fort Worth, TX United States

Houston, TX United States

Huntsville, TX United States

Kingwood, TX United States

Lubbock, TX United States

McKinney, TX United States

Burlington, VT United States

Newport News, VA United States

Bellingham, WA United States

Tacoma, WA United States

Huntington, WV United States

Bahia Blanca, Argentina

Buenos Aires, Argentina

Caba, Argentina

Ciudad Autonoma De Buenos Aires, Argentina

Cordoba, Argentina

Córdoba, Argentina

La Plata, Argentina

Mar Del Plata, Argentina

Mendoza, Argentina

Merlo, Argentina

Quilmes, Argentina

Resistencia, Argentina

Rosario, Argentina

San Miguel De Tucuman, Argentina

San Nicolas, Argentina

Santa Fe, Argentina

Santiago Del Estero, Argentina

Tucuman, Argentina

Vicente Lopez, Argentina

Bedford, Australia

Cairns, Australia

Concord, Australia

Darlinghurst, Australia

Hobart, Australia

Launceston, Australia

Perth, Australia

Sydney, Australia

Wollongong, Australia

Woolloongabba, Australia

Belo Horizonte, Brazil

Belém, Brazil

Blumenal, Brazil

Brasília, Brazil

Campina Grande Do Sul, Brazil

Campinas, Brazil

Campo Grande, Brazil

Canoas, Brazil

Curitiba, Brazil

Goiania, Brazil

Goiânia, Brazil

Marília, Brazil

Passo Fundo, Brazil

Porto Alegre, Brazil

Recife, Brazil

Ribeirão Preto, Brazil

Rio De Janeiro, Brazil

Salvador, Brazil

São Jose Do Rio Preto, Brazil

São Paulo, Brazil

São Pedro, Brazil

Tatuí, Brazil

Uberlândia, Brazil

Votuporanga, Brazil

Blagoevgrad, Bulgaria

Burgas, Bulgaria

Dimitrovgrad, Bulgaria

Kazanlak, Bulgaria

Pazardzhik, Bulgaria

Pleven, Bulgaria

Plovdiv, Bulgaria

Ruse, Bulgaria

Sofia, Bulgaria

Stara Zagora, Bulgaria

Varna, Bulgaria

Veliko Tarnovo, Bulgaria

Edmonton, AB Canada

Maple Ridge, BC Canada

St. John'S, NL Canada

Halifax, NS Canada

Cambridge, ON Canada

Kitchener, ON Canada

London, ON Canada

Ottawa, ON Canada

Scarborough, ON Canada

Toronto, ON Canada

Montreal, QC Canada

Montréal, QC Canada

Baotou, China

Beijing, China

Changchun, China

Changsha, China

Chengdu, China

Daqing, China

Guangzhou, China

Haikou, China

Hangzhou, China

Hunan, China

Jinan, China

Jining, China

Lanzhou, China

Nanchang, China

Nanjing, China

Nanning, China

Qingdao, China

Shanghai, China

Shenyang, China

Shijiazhuang, China

Suzhou, China

Taiyuan, China

Tianjin, China

Wuhan, China

Xi'An, China

Xian, China

Yang Zhou, China

Yichang, China

Brno, Czechia

Hodonín, Czechia

Hradec Králové, Czechia

Hranice, Czechia

Karlovy Vary, Czechia

Kladno, Czechia

Kolín, Czechia

Litomyšl, Czechia

Mladá Boleslav, Czechia

Olomouc, Czechia

Plze?-Bory, Czechia

Praha 10, Czechia

Praha 8 - Libe?, Czechia

Praha, Czechia

Slany, Czechia

Teplice, Czechia

Uherské Hradišt?, Czechia

Valašské Mezi?Í?Í, Czechia

Esbjerg, Denmark

Herlev, Denmark

Hjørring, Denmark

Hvidovre, Denmark

Køge, Denmark

Tallinn, Estonia

Besancon, France

Bron Cedex, France

Chambray-Lès-Tours, France

Corbeil Essonnes, France

Lille, France

Montpellier, France

Nantes, France

Nice, France

Pau, France

Rouen, France

Toulouse, France

Vandoeuvre-Les-Nancy, France

Berlin, Germany

Bielefeld, Germany

Bonn, Germany

Coburg, Germany

Dresden, Germany

Halle, Germany

Hamburg, Germany

Heidelberg, Germany

Konstanz, Germany

Langen, Germany

Leipzig, Germany

Ludwigshafen, Germany

Magdeburg, Germany

Mainz, Germany

Markkleeberg, Germany

Papenburg, Germany

Stuttgart, Germany

Ulm, Germany

Witten, Germany

Heraklion -Crete, Greece

Larisa, Greece

Thessalonikis, Greece

Voula, Greece

Balatonfüred, Hungary

Berettyóújfalu, Hungary

Budapest, Hungary

Gyor, Hungary

Miskolc, Hungary

Nagykanizsa, Hungary

Szekszárd, Hungary

Szolnok, Hungary

Székesfehérvár, Hungary

Zalaegerszeg, Hungary

Aichi, Japan

Chiba, Japan

Chikushino-Shi, Japan

Ehime, Japan

Fukuoka, Japan

Gifu, Japan

Gunma, Japan

Hatsukaichi, Japan

Hitachi, Japan

Hokkaido, Japan

Hyogo, Japan

Ibaraki, Japan

Ishikawa, Japan

Izumo, Japan

Kagawa, Japan

Kahoku-District, Japan

Kanagawa, Japan

Kobe-Shi, Japan

Komatsushima-Shi, Japan

Koshigaya-Shi, Japan

Kumamoto, Japan

Kyoto, Japan

Miyazaki, Japan

Nagano-Shi, Japan

Nagano, Japan

Nagasaki, Japan

Nagoya, Japan

Niigata, Japan

Oita, Japan

Okayama, Japan

Okinawa, Japan

Osaka-Shi, Japan

Osaka, Japan

Saga, Japan

Saitama, Japan

Sapporo, Japan

Sendai, Japan

Shiga, Japan

Shimane, Japan

Shizuoka, Japan

Tachikawa, Japan

Takaraduka, Japan

Tochigi, Japan

Tokushima, Japan

Tokyo, Japan

Toyama, Japan

Toyoake, Japan

Tsu, Japan

Wakayama, Japan

Yamaguchi, Japan

Yatsushiro, Japan

Yokohama, Japan

Yonago, Japan

Busan, Korea, Republic of

Cheongju, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Gwangju, Korea, Republic of

Seongnam-Si, Korea, Republic of

Seoul, Korea, Republic of

Wonju, Korea, Republic of

Daugavpils, Latvia

Kuldiga, Latvia

Liepaja, Latvia

Riga, Latvia

Sigulda, Latvia

Ventspils, Latvia

Alytus, Lithuania

Kaunas, Lithuania

Klaipeda, Lithuania

Panevezys, Lithuania

Siauliai, Lithuania

Vilnius, Lithuania

Cheras, Malaysia

Johor Bahru, Malaysia

Kota Kinabalu, Malaysia

Kuala Lumpur, Malaysia

Kuching, Malaysia

Penang, Malaysia

Selangor, Malaysia

Selayang, Malaysia

Aguascalientes, Mexico

Benito Juárez, Mexico

Chihuahua, Mexico

Culiacan, Mexico

Durango, Mexico

Guadalajara, Mexico

León, Mexico

Mexico City, Mexico

Mexico, Mexico

Oaxaca, Mexico

Pachuca, Mexico

Puebla, Mexico

Queretaro, Mexico

San Luis Potosí, Mexico

Tampico, Mexico

Veracruz, Mexico

Almere, Netherlands

Amsterdam, Netherlands

Blaricum, Netherlands

Breda, Netherlands

Deventer, Netherlands

Doetinchem, Netherlands

Ede, Netherlands

Groningen, Netherlands

Heerlen, Netherlands

Helmond, Netherlands

Maastricht, Netherlands

Meppel, Netherlands

Tilburg, Netherlands