Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
NCT ID: NCT00643201
Last Updated: 2014-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5614 participants
INTERVENTIONAL
2008-07-31
2013-03-31
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
TREATMENT
DOUBLE
Study Groups
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Apixaban
apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
Enoxaparin + Warfarin
Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Interventions
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Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of DVT or PE
Exclusion Criteria
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
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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Alabama Clinical Therapeutics, Llc
Birmingham, Alabama, United States
Horizon Research Group, Inc.
Mobile, Alabama, United States
Fort Smith Lung Center
Fort Smith, Arkansas, United States
University Of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
Beaver Medical Group
Banning, California, United States
University Of California San Francisco-Fresno
Fresno, California, United States
University Of California, Davis Medical Center
Sacramento, California, United States
Chest Medicine & Critical Care Medical Gr. Inc.
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Harbor Ucla Medical Center
Torrance, California, United States
New West Physicians
Golden, Colorado, United States
Drogue Medical, Llc
Wheat Ridge, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med
New Haven, Connecticut, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Bay Pines Va Healthcare Systems
Bay Pines, Florida, United States
Daniel G. Lorch, Jr, Md, Cpi
Brandon, Florida, United States
Research Alliance, Inc.
Clearwater, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Pasadena Center For Medical Research
St. Petersburg, Florida, United States
Tampa Clinical Research
Tampa, Florida, United States
Office Of Michele S. Maholtz Md
Vero Beach, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta Pulmonary Group
Atlanta, Georgia, United States
Atlanta Institute For Medical Research, Inc
Decatur, Georgia, United States
Chatham Hospitalists
Savannah, Georgia, United States
Gateway Cardiology. P.C
Jerseyville, Illinois, United States
West Suburban Medical Center
Oak Park, Illinois, United States
Infectious Disease Of Indiana Psc
Carmel, Indiana, United States
Heartland Vascular Medicine And Surgery
Windsor Heights, Iowa, United States
Kentucky Lung Clinic
Hazard, Kentucky, United States
Univ. Of Kentucky Dept. Of Surgery
Lexington, Kentucky, United States
Research Integrity, Llc
Owensboro, Kentucky, United States
Pen Bay Medical Center
Rockport, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Medstar Research Health Institute
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Mississippi Medical Research, Llc
Picayune, Mississippi, United States
University Of Missouri-Columbia
Columbia, Missouri, United States
Veterans Affairs Medical Center
Kansas City, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
St. John'S Mercy Medical Center
St Louis, Missouri, United States
Mercury Street Medical Group, Pllc
Butte, Montana, United States
Great Falls Clinic, Llp
Great Falls, Montana, United States
Internal Medical Associates Of Grand Island, P.C
Grand Island, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Pulmonary & Critical Care Services, Pc
Albany, New York, United States
Kaleida Health System
Buffalo, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
New York Medical College
Valhalla, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Rex Healthcare
Raleigh, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Clinical Trials Of America, Inc.
Winston-Salem, North Carolina, United States
Altru Health System Clinic
Grand Forks, North Dakota, United States
Huron Hospital
Cleveland, Ohio, United States
Remington Davis Inc.
Columbus, Ohio, United States
Oregon Health Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Kore Cv Research
Jackson, Tennessee, United States
Primecare Medical Group
Houston, Texas, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
University Of Utah Medical Center
Salt Lake City, Utah, United States
Lake Washington Vascular, Pllc
Bellevue, Washington, United States
Franciscan Research Center
Tacoma, Washington, United States
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Livingston, West Lothian, United Kingdom
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References
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Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.
Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.
Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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EUDRACT: 2007-007867-25
Identifier Type: -
Identifier Source: secondary_id
CV185-056
Identifier Type: -
Identifier Source: org_study_id
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