Safety Study of Apixaban in Recent Acute Coronary Syndrome
NCT ID: NCT00313300
Last Updated: 2015-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1741 participants
INTERVENTIONAL
2006-05-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A1
Apixaban
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
A2
Apixaban
Tablets, Oral, 10 mg, once daily, 26 weeks
A3
Placebo
Tablets, Oral, 0, twice daily, 26 weeks
A4
Apixaban
Tablets, Oral 10 mg, twice daily, 26 weeks
Interventions
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Apixaban
Tablets, Oral, 2.5 mg, twice daily, 26 weeks
Apixaban
Tablets, Oral, 10 mg, once daily, 26 weeks
Placebo
Tablets, Oral, 0, twice daily, 26 weeks
Apixaban
Tablets, Oral 10 mg, twice daily, 26 weeks
Eligibility Criteria
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Inclusion Criteria
* Clinically stable on optimal treatment
Exclusion Criteria
* Ongoing anticoagulant use.
* Need for chronic (\>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (\>325 mg/day
18 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Scottsdale Cardiovasular Research Institute
Scottsdale, Arizona, United States
Los Angeles County & University Of Southern Ca. Medical Cen.
Los Angeles, California, United States
Radiant Research,Santa Rosa
Santa Rosa, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Watson Clinic Center For Research
Lakeland, Florida, United States
Heart & Vasc Inst Of Fl
Safety Harbor, Florida, United States
Indian River Medical Center
Vero Beach, Florida, United States
Cardiac Disease Specialists, P.C.
Atlanta, Georgia, United States
Georgia Heart Specialists
Covington, Georgia, United States
Heartcare Midwest
Peoria, Illinois, United States
The Care Group, Llc.
Indianapolis, Indiana, United States
Iowa Heart Center
Des Moines, Iowa, United States
University Of Kentucky
Lexington, Kentucky, United States
William Beaumont Hospital-Troy
Troy, Michigan, United States
New York Cardiovascular Associates
New York, New York, United States
Unc Hospitals, Department Of Medicine
Chapel Hill, North Carolina, United States
Dumc
Durham, North Carolina, United States
Carolina Heart Specialists
Gastonia, North Carolina, United States
Piedmont Cardiology Associates
Hickory, North Carolina, United States
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, United States
Midwest Cardiology Research Foundation
Columbus, Ohio, United States
The Dayton Heart Center
Dayton, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Geisinger Clinic - Cardiology
Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Cardiovascular Associates, P.C
Kingsport, Tennessee, United States
University Of Texas Medical School - San Antonio
San Antonio, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Local Institution
Feldkirch, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Huy, Luik, Belgium
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Aalst, , Belgium
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Antwerp, , Belgium
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Brasschaat, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Belleville, Ontario, Canada
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Chatham, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Terrebonne, Quebec, Canada
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Arhus C, , Denmark
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Copenhagen, , Denmark
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Esbjerg, , Denmark
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Frederiksberg, , Denmark
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Glostrup Municipality, , Denmark
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Hellerup, , Denmark
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Herning, , Denmark
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Randers, , Denmark
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Amiens, , France
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Cholet, , France
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Dijon, , France
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Nantes, , France
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Paris, , France
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Pessac, , France
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Roubaix, , France
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Toulouse, , France
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Berlin, , Germany
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Berlin, , Germany
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Düren, , Germany
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Halle, , Germany
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Hanover, , Germany
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Krefeld, , Germany
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Langen, , Germany
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Ludwigshafen, , Germany
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Witten, , Germany
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Afula, , Israel
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Hadera, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nazareth, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Roma, , Italy
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Opole, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Zielona Góra, , Poland
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Yaroslavl, , Russia
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Yaroslav, , Russia
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Baracaldo (Vizcaya), , Spain
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Barcelona, , Spain
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Hospitalet Llobregat Barcelona, , Spain
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León, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Tarragona, , Spain
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Valladolid, , Spain
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Villajoyosa, , Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Malmo, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Uppsala, , Sweden
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Stockport, Cheshire, United Kingdom
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Harrow, Middlesex, United Kingdom
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Edinburgh, Midlothian, United Kingdom
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Portadown, Northern Ireland, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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York, Yorkshire, United Kingdom
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Croydon, , United Kingdom
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Leicester, , United Kingdom
Countries
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References
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APPRAISE Steering Committee and Investigators; Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.
Other Identifiers
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CV185-023
Identifier Type: -
Identifier Source: org_study_id