An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00809965
First received: December 16, 2008
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Myocardial Infarction
Myocardial Ischemia
Unstable Angina
Drug: Rivaroxaban 2.5 mg
Drug: Rivaroxaban 5 mg
Drug: Placebo
Drug: Standard of care
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 15526
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Drug: Rivaroxaban 2.5 mg
One tablet twice daily
Drug: Standard of care
Experimental: Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
Drug: Rivaroxaban 5 mg
One tablet twice daily
Drug: Standard of care
Placebo Comparator: Placebo
One placebo tablet twice daily for up to 6 months
Drug: Placebo
One placebo tablet twice daily
Drug: Standard of care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00809965

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Geneva, Alabama, United States
Mobile, Alabama, United States
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
United States, Colorado
Aurora, Colorado, United States
Littleton, Colorado, United States
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
United States, Georgia
Columbus, Georgia, United States
Rome, Georgia, United States
United States, Illinois
Aurora, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
Merrillville, Indiana, United States
Munster, Indiana, United States
Valparaiso, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
Wichita, Kansas, United States
United States, Louisiana
Lacombe, Louisiana, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
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
United States, Mississippi
Tupelo, Mississippi, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Montana
Kalispell, Montana, United States
United States, New Jersey
Bridgewater, New Jersey, United States
Linden, New Jersey, United States
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
United States, North Carolina
Winston Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Fairview Park, Ohio, United States
United States, Oklahoma
Bartlesville, Oklahoma, United States
Oklahoma City, Oklahoma, United States
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
United States, South Carolina
Greenville, South Carolina, United States
United States, Tennessee
Johnson City, Tennessee, United States
Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Odessa, Texas, United States
Tomball, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
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Burlington, Vermont, United States
United States, Virginia
Danville, Virginia, United States
Roanoke, Virginia, United States
United States, Washington
Spokane, Washington, United States
United States, Wisconsin
Wausau, Wisconsin, United States
Argentina
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
Australia
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
Belgium
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Brussels, Belgium
Eupen, Belgium
Genk, Belgium
Huy, Belgium
Leuven, Belgium
Mol, Belgium
Tienen, Belgium
Brazil
Belo Horizonte, Brazil
Blumenau, Brazil
Campina Grande Do Sul, Brazil
Campinas, Brazil
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Recife, Brazil
Ribeirao Preto, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Sao Jose Do Rio Preto, Brazil
Sao Paulo, Brazil
São Paulo, Brazil
Bulgaria
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Dimitrovgrad, Bulgaria
Haskovo, Bulgaria
Pazardjik, Bulgaria
Pleven, Bulgaria
Plovdiv, Bulgaria
Rousse, Bulgaria
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Sofia, Bulgaria
Varna, Bulgaria
Veliko Tarnovo, Bulgaria
Canada, Alberta
Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
Maple Ridge, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
St. John'S, Newfoundland and Labrador, Canada
Canada, Ontario
London, Ontario, Canada
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Ottawa, Ontario, Canada
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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
Canada, Saskatchewan
North Battleford, Saskatchewan, Canada
Canada
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Chile
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Chile, Chile
Osorno X Región, Chile
Punta Arenas, Chile
San Bernardo, Chile
Santiago, Chile
Santiago Rm, Chile
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China
Beijing, China
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Harbin, China
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Nanjing, China
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Shen Yang, China
Shenyang, China
Tianjin, China
Xi'An, China
Colombia
Armenia, Colombia
Barranquilla, Colombia
Bogotá Dc, Colombia
Cali Valle Del Cauca, Colombia
Envigado, Colombia
Manizales, Colombia
Medellin, Colombia
Santander, Colombia
Croatia
Rijeka, Croatia
Slavonski Brod, Croatia
Suska 6, Croatia
Czech Republic
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
Denmark
Aalborg, Denmark
Esbjerg, Denmark
Holbæk, Denmark
Horsens N/A, Denmark
Kolding, Denmark
København, Denmark
Odense, Denmark
Egypt
Alexandria, Egypt
Cairo, Egypt
Ismailia, Egypt
Menofeya, Egypt
France
Besancon, France
Cannes, France
Chambray-Les-Tours, France
Chartres, France
Creteil N/A, France
Dijon, France
Haguenau, France
Lagny, France
Marseille, France
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Paris, France
Poitiers, France
Germany
Bad Friedrichshall, Germany
Berlin, Germany
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Dresden, Germany
Essen, Germany
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Greifswald, Germany
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Greece
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Hungary
Budapest, Hungary
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India
Ahmedabad, India
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Nagpur, India
Nasik, India
New Delhi, India
Pune, India
Surat, India
Trissur, India
Trivandrum, India
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Vijayawada, India
Israel
Afula, Israel
Hadera, Israel
Haifa, Israel
Jerusalem, Israel
Nahariya, Israel
Petah Tikva, Israel
Rehovot, Israel
Safed, Israel
Tel Aviv, Israel
Tiberias, Israel
Japan
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
Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Seognam-Si, Kyungki-Do, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Latvia
Daugavpils, Latvia
Liepaja, Latvia
Riga, Latvia
Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Siauliai, Lithuania
Vilnius, Lithuania
Vilnius Lt, Lithuania
Malaysia
Johor Bahru, Malaysia
Kelantan, Malaysia
Kota Samarahan, Malaysia
Kuala Lumpur, Malaysia
Selayang N/A, Malaysia
Mexico
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
Morocco
Marrakech, Morocco
Meknès, Morocco
Rabat, Morocco
Netherlands
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
New Zealand
Auckland, New Zealand
Dunedin, New Zealand
Hamilton, New Zealand
Lower Hutt, New Zealand
Nelson, New Zealand
New Plymouth, New Zealand
Philippines
Iloilo City, Philippines
Marikina City, Philippines
Quezon City, Philippines
Poland
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
Portugal
Aveiro, Portugal
Braga, Portugal
Coimbra, Portugal
Faro, Portugal
Leiria, Portugal
Lisboa, Portugal
Penafiel, Portugal
Porto, Portugal
Vila Nova De Gaia, Portugal
Romania
Bucuresti, Romania
Craiova, Romania
Focsani, Romania
Oradea, Romania
Pitesti, Romania
Tg Mures, Romania
Timisoara, Romania
Russian Federation
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
Serbia
Belgrade, Serbia
Beograd, Serbia
Kragujevac, Serbia
Nis, Serbia
Niska Banja, Serbia
Slovakia
Bratislava, Slovakia
Nové Zámky, Slovakia
Zilina, Slovakia
Spain
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
Sweden
Danderyd, Sweden
Göteborg, Sweden
Jönköping, Sweden
Linköping, Sweden
Lund, Sweden
Malmö, Sweden
Umeå, Sweden
Örebro, Sweden
Östersund, Sweden
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Pathumthani, Thailand
Phathumwan, Thailand
Tunisia
Sfax, Tunisia
Sousse, Tunisia
Tunis, Tunisia
Turkey
Ankara, Turkey
Aydin, Turkey
Bursa, Turkey
Erzurum, Turkey
Istanbul, Turkey
Izmir, Turkey
Kayseri, Turkey
Samsun, Turkey
Sivas, Turkey
Ukraine
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
United Kingdom
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
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: NCT00809965     History of Changes
Other Study ID Numbers: CR014710, RIVAROXACS3001
Study First Received: December 16, 2008
Results First Received: May 5, 2014
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
Croatia: Ministry of Health and Social Care
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Rivaroxaban
Acute Coronary Syndrome
ACS
Aspirin
Thienopyridine
Unstable Angina
Myocardial Infarction
Anticoagulation
Clopidogrel (Plavix)

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Unstable
Coronary Artery Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Disease
Disease
Heart Diseases
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014