An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
August 26, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Acute coronary syndrome (ACS) is a serious and life threatening condition.
Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke.
Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients.
This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS.
Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
15526
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina
-
Cordoba, Argentina
-
Corrientes, Argentina
-
Junin, Argentina
-
La Plata, Argentina
-
Mar Del Plata, Argentina
-
Moron, Argentina
-
Morón, Argentina
-
Resistencia, Argentina
-
Rosario, Argentina
-
Salta, Argentina
-
San Luis, Argentina
-
Santa Fe, Argentina
-
Tucuman, Argentina
-
-
-
-
-
Bedford Park, Australia
-
Chermside N/A, Australia
-
Coffs Harbour South, Australia
-
Douglas, Australia
-
Epping, Australia
-
Fremantle, Australia
-
Heidelberg, Australia
-
Herston, Australia
-
Launceston, Australia
-
Milton, Australia
-
Newcastle, Australia
-
Parkville, Australia
-
Perth, Australia
-
Southport, Australia
-
Woolloongabba N/A, Australia
-
-
-
-
-
Bonheiden, Belgium
-
Brussels, Belgium
-
Eupen, Belgium
-
Genk, Belgium
-
Huy, Belgium
-
Leuven, Belgium
-
Mol, Belgium
-
Tienen, Belgium
-
-
-
-
-
Belo Horizonte, Brazil
-
Blumenau, Brazil
-
Campina Grande Do Sul, Brazil
-
Campinas, Brazil
-
Curitiba, Brazil
-
Porto Alegre, Brazil
-
Recife, Brazil
-
Ribeirao Preto, Brazil
-
Rio De Janeiro, Brazil
-
Salvador, Brazil
-
Sao Jose Do Rio Preto, Brazil
-
Sao Paulo, Brazil
-
São Paulo, Brazil
-
-
-
-
-
Bourgas, Bulgaria
-
Dimitrovgrad, Bulgaria
-
Haskovo, Bulgaria
-
Pazardjik, Bulgaria
-
Pleven, Bulgaria
-
Plovdiv, Bulgaria
-
Rousse, Bulgaria
-
Sevlievo, Bulgaria
-
Sofia, Bulgaria
-
Varna, Bulgaria
-
Veliko Tarnovo, Bulgaria
-
-
-
-
-
Laval, Canada
-
-
Alberta
-
Edmonton, Alberta, Canada
-
-
British Columbia
-
Kelowna, British Columbia, Canada
-
Maple Ridge, British Columbia, Canada
-
Victoria, British Columbia, Canada
-
-
Newfoundland and Labrador
-
St. John'S, Newfoundland and Labrador, Canada
-
-
Ontario
-
London, Ontario, Canada
-
Newmarket, Ontario, Canada
-
Oshawa, Ontario, Canada
-
Ottawa, Ontario, Canada
-
Sudbury, Ontario, Canada
-
-
Quebec
-
Granby, Quebec, Canada
-
Montreal, Quebec, Canada
-
Quebec City, Quebec, Canada
-
Saint-Charles-Borromee, Quebec, Canada
-
Saint-Georges, Quebec, Canada
-
Sherbrooke, Quebec, Canada
-
Ste-Foy, Quebec, Canada
-
-
Saskatchewan
-
North Battleford, Saskatchewan, Canada
-
-
-
-
-
Antofagasta, Chile
-
Chile, Chile
-
Osorno X Región, Chile
-
Punta Arenas, Chile
-
San Bernardo, Chile
-
Santiago, Chile
-
Santiago Rm, Chile
-
Talcahuano, Chile
-
Temuco, Chile
-
Valdivia X Región, Chile
-
Victoria, Chile
-
Vina Del Mar, Chile
-
-
-
-
-
Beijing, China
-
Beijing Prc, China
-
Changsha, China
-
Daqing, China
-
Guangzhou, China
-
Hangzhou, China
-
Harbin, China
-
Jinan, China
-
Nanjing, China
-
Shanghai, China
-
Shen Yang, China
-
Shenyang, China
-
Tianjin, China
-
Xi'An, China
-
-
-
-
-
Armenia, Colombia
-
Barranquilla, Colombia
-
Bogotá Dc, Colombia
-
Cali Valle Del Cauca, Colombia
-
Envigado, Colombia
-
Manizales, Colombia
-
Medellin, Colombia
-
Santander, Colombia
-
-
-
-
-
Rijeka, Croatia
-
Slavonski Brod, Croatia
-
Suska 6, Croatia
-
-
-
-
-
Benesov Nad Cernou, Czech Republic
-
Brno, Czech Republic
-
Ceske Budejovice, Czech Republic
-
Cesky Krumlov N/A, Czech Republic
-
Hradec Kralove, Czech Republic
-
Kolin N/A, Czech Republic
-
Kromeriz, Czech Republic
-
Litomysl, Czech Republic
-
Nachod N/A, Czech Republic
-
Pardubice N/A, Czech Republic
-
Plzeò 1, Czech Republic
-
Poruba, Czech Republic
-
Praha, Czech Republic
-
Praha 10 N/A, Czech Republic
-
Praha 2, Czech Republic
-
Praha 8, Czech Republic
-
Slany, Czech Republic
-
Teplice, Czech Republic
-
Usti Nad Labem, Czech Republic
-
Znojmo N/A, Czech Republic
-
-
-
-
-
Aalborg, Denmark
-
Esbjerg, Denmark
-
Holbæk, Denmark
-
Horsens N/A, Denmark
-
Kolding, Denmark
-
København, Denmark
-
Odense, Denmark
-
-
-
-
-
Alexandria, Egypt
-
Cairo, Egypt
-
Ismailia, Egypt
-
Menofeya, Egypt
-
-
-
-
-
Besancon, France
-
Cannes, France
-
Chambray-Les-Tours, France
-
Chartres, France
-
Creteil N/A, France
-
Dijon, France
-
Haguenau, France
-
Lagny, France
-
Marseille, France
-
Montfermeil, France
-
Paris, France
-
Poitiers, France
-
-
-
-
-
Bad Friedrichshall, Germany
-
Berlin, Germany
-
Bonn, Germany
-
Dresden, Germany
-
Essen, Germany
-
Esslingen, Germany
-
Frankfurt / Main, Germany
-
Freiburg, Germany
-
Greifswald, Germany
-
Göttingen, Germany
-
Halle, Germany
-
Hamburg, Germany
-
Hannover, Germany
-
Heidelberg, Germany
-
Kiel, Germany
-
Leipzig, Germany
-
Limburg, Germany
-
Lübeck, Germany
-
Magdeburg, Germany
-
Mannheim, Germany
-
Weiden, Germany
-
Wermsdorf, Germany
-
Witten, Germany
-
-
-
-
-
Athens, Greece
-
Larisa, Greece
-
Rhodes, Greece
-
Thessalonikis, Greece
-
-
-
-
-
Budapest, Hungary
-
Budapest N/A, Hungary
-
Debrecen, Hungary
-
Győr, Hungary
-
Kecskemet, Hungary
-
Komarom, Hungary
-
Miskolc, Hungary
-
Szolnok, Hungary
-
Szombathely, Hungary
-
Zalaegerszeg, Hungary
-
-
-
-
-
Ahmedabad, India
-
Allahabad, India
-
Bangalore, India
-
Chandigarh, India
-
Chennai, India
-
Cochin, India
-
Coimbatore, India
-
Ernakulam, India
-
Gandhinagar Guiarat, India
-
Gurgaon, India
-
Hyderabad, India
-
Jaipur, India
-
Karamsad, India
-
Kochi, India
-
Kolkata, India
-
Lucknow Gpo, India
-
Ludhiana, India
-
Madurai, India
-
Mangalore, India
-
Mumbai, India
-
Mysore, India
-
Nagpur, India
-
Nasik, India
-
New Delhi, India
-
Pune, India
-
Surat, India
-
Trissur, India
-
Trivandrum, India
-
Vadodara, India
-
Vijayawada, India
-
-
-
-
-
Afula, Israel
-
Hadera, Israel
-
Haifa, Israel
-
Jerusalem, Israel
-
Nahariya, Israel
-
Petah Tikva, Israel
-
Rehovot, Israel
-
Safed, Israel
-
Tel Aviv, Israel
-
Tiberias, Israel
-
-
-
-
-
Anan, Japan
-
Fukui, Japan
-
Fukuoka-Shi,, Japan
-
Fukuyama-City,, Japan
-
Gifu-City, Japan
-
Higashiosaka-City, Japan
-
Kagoshima-City, Japan
-
Kanazawa-City, Japan
-
Kasuga, Japan
-
Kawachinagano-City, Japan
-
Kawasaki-City, Japan
-
Kisarazu-City, Japan
-
Kobe-City, Japan
-
Kobe-Shi, Japan
-
Kumamoto, Japan
-
Kumamoto-City, Japan
-
Kuwana-City, Japan
-
Maebashi-City Gunma, Japan
-
Matsudo-City, Japan
-
Matsumoto, Japan
-
Matsuyama-City Ehime, Japan
-
Miyazaki-Gun, Japan
-
Nagano-City, Japan
-
Nagasaki, Japan
-
Nagoya, Japan
-
Nagoya-City, Japan
-
Namegata-City, Japan
-
Nankoku-City, Japan
-
Nishinomiya, Japan
-
Okayama-City, Japan
-
Osaka, Japan
-
Osaka-City, Japan
-
Sakaide-City, Japan
-
Sakura-Shi, Japan
-
Suwa-City, Japan
-
Tokushima, Japan
-
Tokushima-City, Japan
-
Tokyo, Japan
-
Tokyo,, Japan
-
Toyama-City, Japan
-
Urasoe-City, Japan
-
Yamaguchi, Japan
-
Yokohama, Japan
-
Yokohama N/A, Japan
-
Yokohama-City, Japan
-
Yokohama-Shi, Japan
-
Yonago-Shi, Japan
-
-
-
-
-
Daejeon, Korea, Republic of
-
Gwangju, Korea, Republic of
-
Seognam-Si, Kyungki-Do, Korea, Republic of
-
Seoul, Korea, Republic of
-
Suwon, Korea, Republic of
-
-
-
-
-
Daugavpils, Latvia
-
Liepaja, Latvia
-
Riga, Latvia
-
-
-
-
-
Kaunas, Lithuania
-
Klaipeda, Lithuania
-
Siauliai, Lithuania
-
Vilnius, Lithuania
-
Vilnius Lt, Lithuania
-
-
-
-
-
Johor Bahru, Malaysia
-
Kelantan, Malaysia
-
Kota Samarahan, Malaysia
-
Kuala Lumpur, Malaysia
-
Selayang N/A, Malaysia
-
-
-
-
-
Aguascalientes, Mexico
-
Cd. Juarez, Mexico
-
Ciudad De Mexico, Mexico
-
Culiacan, Mexico
-
Guadalajara, Mexico
-
Leon, Mexico
-
Mexico, Mexico
-
Monterrey, Mexico
-
Queretaro, Mexico
-
San Luis Potosi, Mexico
-
Sinaloa, Mexico
-
Veracruz, Mexico
-
Zapopan, Mexico
-
-
-
-
-
Marrakech, Morocco
-
Meknès, Morocco
-
Rabat, Morocco
-
-
-
-
-
Amsterdam, Netherlands
-
Arnhem, Netherlands
-
Delft, Netherlands
-
Den Haag, Netherlands
-
Eindhoven, Netherlands
-
Gorinchem, Netherlands
-
Gouda, Netherlands
-
Haarlem, Netherlands
-
Harderwijk, Netherlands
-
Hengelo Ov, Netherlands
-
Nieuwegein, Netherlands
-
Nijmegen, Netherlands
-
Sittard, Netherlands
-
Vlaardingen, Netherlands
-
-
-
-
-
Auckland, New Zealand
-
Dunedin, New Zealand
-
Hamilton, New Zealand
-
Lower Hutt, New Zealand
-
Nelson, New Zealand
-
New Plymouth, New Zealand
-
-
-
-
-
Iloilo City, Philippines
-
Marikina City, Philippines
-
Quezon City, Philippines
-
-
-
-
-
Bedzin, Poland
-
Białystok, Poland
-
Bielsko-Biala, Poland
-
Bydgoszcz, Poland
-
Bytom, Poland
-
Dąbrowa Górnicza, Poland
-
Gdynia, Poland
-
Gorlice, Poland
-
Katowice, Poland
-
Katowice N/A, Poland
-
Katowice-Ochojec, Poland
-
Koszalin, Poland
-
Krakow, Poland
-
Krakow N/A, Poland
-
Kutno, Poland
-
Lodz, Poland
-
Nowy Targ, Poland
-
Opole, Poland
-
Plock, Poland
-
Poznan, Poland
-
Poznan N/A, Poland
-
Ruda Slaska, Poland
-
Starogard Gdanski Nap, Poland
-
Szczecin, Poland
-
Szczecin N/A, Poland
-
Torun, Poland
-
Warszawa, Poland
-
Warszawa N/A, Poland
-
Wloclawek, Poland
-
Wroclaw, Poland
-
Zamosc, Poland
-
-
-
-
-
Aveiro, Portugal
-
Braga, Portugal
-
Coimbra, Portugal
-
Faro, Portugal
-
Leiria, Portugal
-
Lisboa, Portugal
-
Penafiel, Portugal
-
Porto, Portugal
-
Vila Nova De Gaia, Portugal
-
-
-
-
-
Bucuresti, Romania
-
Craiova, Romania
-
Focsani, Romania
-
Oradea, Romania
-
Pitesti, Romania
-
Tg Mures, Romania
-
Timisoara, Romania
-
-
-
-
-
Arkhangelsk, Russian Federation
-
Barnaul, Russian Federation
-
Chelyabinsk, Russian Federation
-
Ekaterinburg, Russian Federation
-
Ivanovo, Russian Federation
-
Kaliningrad, Russian Federation
-
Kemerovo, Russian Federation
-
Kirov, Russian Federation
-
Krasnodar, Russian Federation
-
Krasnoyarsk, Russian Federation
-
Kursk, Russian Federation
-
Lyubertsy, Russian Federation
-
Moscow, Russian Federation
-
Moscow N/A, Russian Federation
-
Nizhny Novgorod, Russian Federation
-
Novosibirsk, Russian Federation
-
Omsk, Russian Federation
-
Orenburg, Russian Federation
-
Penza, Russian Federation
-
Perm, Russian Federation
-
Pskov, Russian Federation
-
Pushkin, Saint-Petersburg, Russian Federation
-
Ryazan, Russian Federation
-
Saint-Petersbrug, Russian Federation
-
Saint-Petersburg, Russian Federation
-
Sestroretsk, Saint-Petersburg, Russian Federation
-
St Petersburg, Russian Federation
-
St Petersburg N/A, Russian Federation
-
St. Petersburg, Russian Federation
-
Syktyvkar, Russian Federation
-
Tomsk, Russian Federation
-
Tula, Russian Federation
-
Tumen Region, Russian Federation
-
Vladimir, Russian Federation
-
Voronezh, Russian Federation
-
Yaroslavl Nap, Russian Federation
-
-
-
-
-
Belgrade, Serbia
-
Beograd, Serbia
-
Kragujevac, Serbia
-
Nis, Serbia
-
Niska Banja, Serbia
-
-
-
-
-
Bratislava, Slovakia
-
Nové Zámky, Slovakia
-
Zilina, Slovakia
-
-
-
-
-
Alicante N/A, Spain
-
Aviles Asturias, Spain
-
Barcelona, Spain
-
Burgos, Spain
-
Elche, Spain
-
Figueres, Spain
-
Guadalajara, Spain
-
Huelva N/A, Spain
-
Madrid, Spain
-
Malaga, Spain
-
Málaga, Spain
-
Salamanca, Spain
-
Santander, Spain
-
Sevilla, Spain
-
Tarragona, Spain
-
Valencia, Spain
-
Vigo, Spain
-
-
-
-
-
Danderyd, Sweden
-
Göteborg, Sweden
-
Jönköping, Sweden
-
Linköping, Sweden
-
Lund, Sweden
-
Malmö, Sweden
-
Umeå, Sweden
-
Örebro, Sweden
-
Östersund, Sweden
-
-
-
-
-
Bangkok, Thailand
-
Chiang Mai, Thailand
-
Pathumthani, Thailand
-
Phathumwan, Thailand
-
-
-
-
-
Sfax, Tunisia
-
Sousse, Tunisia
-
Tunis, Tunisia
-
-
-
-
-
Ankara, Turkey
-
Aydin, Turkey
-
Bursa, Turkey
-
Erzurum, Turkey
-
Istanbul, Turkey
-
Izmir, Turkey
-
Kayseri, Turkey
-
Samsun, Turkey
-
Sivas, Turkey
-
-
-
-
-
Cherkassy, Ukraine
-
Dnepropetrovsk, Ukraine
-
Donetsk, Ukraine
-
Ivano-Frankivsk, Ukraine
-
Kharkov, Ukraine
-
Khemelnitskiy, Ukraine
-
Kiev, Ukraine
-
Lugansk, Ukraine
-
Lutsk, Ukraine
-
Lviv, Ukraine
-
Nikolaev, Ukraine
-
Poltava, Ukraine
-
Sumy, Ukraine
-
Ternopol, Ukraine
-
Uzhgorod, Ukraine
-
Vinnitsa, Ukraine
-
Zaporozhye, Ukraine
-
Zhytomir, Ukraine
-
-
-
-
-
Birmingham, United Kingdom
-
Blackpool, United Kingdom
-
Bristol, United Kingdom
-
Chertsey, United Kingdom
-
Chesterfield, United Kingdom
-
East Sussex, United Kingdom
-
Exeter, United Kingdom
-
Hampshire, United Kingdom
-
Harrow, United Kingdom
-
Hull, United Kingdom
-
Leicester, United Kingdom
-
Lincoln, United Kingdom
-
Manchester, United Kingdom
-
Middlesbrough, United Kingdom
-
Portadown, United Kingdom
-
Stockport, United Kingdom
-
Warwick, United Kingdom
-
Worcester, United Kingdom
-
-
-
-
Alabama
-
Birmingham, Alabama, United States
-
Geneva, Alabama, United States
-
Mobile, Alabama, United States
-
-
California
-
Anaheim, California, United States
-
Burbank, California, United States
-
Los Angeles, California, United States
-
Mission Hills, California, United States
-
San Diego, California, United States
-
-
Colorado
-
Aurora, Colorado, United States
-
Littleton, Colorado, United States
-
-
Florida
-
Jacksonville, Florida, United States
-
Jupiter, Florida, United States
-
Kissimmee, Florida, United States
-
Miami, Florida, United States
-
Ocala, Florida, United States
-
Orlando, Florida, United States
-
Ormond Beach, Florida, United States
-
St Petersburg, Florida, United States
-
St. Petersburg, Florida, United States
-
-
Georgia
-
Columbus, Georgia, United States
-
Rome, Georgia, United States
-
-
Illinois
-
Aurora, Illinois, United States
-
-
Indiana
-
Indianapolis, Indiana, United States
-
Merrillville, Indiana, United States
-
Munster, Indiana, United States
-
Valparaiso, Indiana, United States
-
-
Kansas
-
Overland Park, Kansas, United States
-
Wichita, Kansas, United States
-
-
Louisiana
-
Lacombe, Louisiana, United States
-
-
Maryland
-
Bethesda, Maryland, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
-
Michigan
-
Flint, Michigan, United States
-
Grand Blanc, Michigan, United States
-
Grand Rapids, Michigan, United States
-
Kalamazoo, Michigan, United States
-
Mount Clemens, Michigan, United States
-
Petoskey, Michigan, United States
-
-
Mississippi
-
Tupelo, Mississippi, United States
-
-
Missouri
-
Saint Louis, Missouri, United States
-
-
Montana
-
Kalispell, Montana, United States
-
-
New Jersey
-
Bridgewater, New Jersey, United States
-
Linden, New Jersey, United States
-
-
New York
-
Buffalo, New York, United States
-
Cortlandt Manor, New York, United States
-
Saratoga Springs, New York, United States
-
Stony Brook, New York, United States
-
Syracuse, New York, United States
-
-
North Carolina
-
Winston Salem, North Carolina, United States
-
-
Ohio
-
Cincinnati, Ohio, United States
-
Cleveland, Ohio, United States
-
Columbus, Ohio, United States
-
Dayton, Ohio, United States
-
Fairview Park, Ohio, United States
-
-
Oklahoma
-
Bartlesville, Oklahoma, United States
-
Oklahoma City, Oklahoma, United States
-
-
Pennsylvania
-
Doylestown, Pennsylvania, United States
-
Langhorne, Pennsylvania, United States
-
Ridley Park, Pennsylvania, United States
-
Sayre, Pennsylvania, United States
-
West Chester, Pennsylvania, United States
-
York, Pennsylvania, United States
-
-
South Carolina
-
Greenville, South Carolina, United States
-
-
Tennessee
-
Johnson City, Tennessee, United States
-
Memphis, Tennessee, United States
-
-
Texas
-
Amarillo, Texas, United States
-
Lubbock, Texas, United States
-
Odessa, Texas, United States
-
Tomball, Texas, United States
-
-
Utah
-
Salt Lake City, Utah, United States
-
-
Vermont
-
Burlington, Vermont, United States
-
-
Virginia
-
Danville, Virginia, United States
-
Roanoke, Virginia, United States
-
-
Washington
-
Spokane, Washington, United States
-
-
Wisconsin
-
Wausau, Wisconsin, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
- Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
- Need for continued anticoagulant therapy
- Significant renal impairment or known significant liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Number of Arms
3
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
|
One tablet twice daily
|
|
Experimental: Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
|
One tablet twice daily
|
|
Placebo Comparator: Placebo
One placebo tablet twice daily for up to 6 months
|
One placebo tablet twice daily
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke.
The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
|
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
The percentage of patients with the first occurrence of the composite endpoint.
The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
|
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
The percentage of patients with the first occurrence of the composite endpoint.
The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
|
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
The percentage of patients with the first occurrence of the composite endpoint.
The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
|
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
|
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
Time Frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
The percentage of patients with the first occurrence of the composite endpoint.
The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
|
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
- Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.
- Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.
- Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.
- Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
- Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.
- Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
Study Start
November 1, 2008
Primary Completion (Actual)
Primary Completion
September 1, 2011
Study Completion (Actual)
Study Completion
September 1, 2011
Study Registration Dates
First Submitted
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
First Posted
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
September 17, 2014
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Disease
- Chest Pain
- Angina Pectoris
- Myocardial Infarction
- Infarction
- Myocardial Ischemia
- Syndrome
- Ischemia
- Acute Coronary Syndrome
- Angina, Unstable
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
Other Study ID Numbers
Other Study ID Numbers
- CR014710
- RIVAROXACS3001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.