Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thrombosis, Pulmonary Embolism

In brief

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Key facts

Study ID

NCT00457002

Run by

Bristol-Myers Squibb

People needed

6758

Starts

2007-06-01

Expected to finish

2011-05-01

Last updated by the study team

2015-12-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• men and non-pregnant, non-breastfeeding women
• 40 years or older
• hospitalized with congestive heart failure or acute respiratory failure
• infection (without septic shock)
• acute rheumatic disorder
• inflammatory bowel disease

You may not qualify if…

• patients with venous thromboembolism (VTE)
• active bleeding or at high risk of bleeding
• unable to take oral medication
• with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Where it is running

• Heart Center Research, Llc — Huntsville, Alabama, United States
• Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
• Az Pulmonary Specialists Ltd — Scottsdale, Arizona, United States
• Fort Smith Lung Center — Fort Smith, Arkansas, United States
• Scripps Clinic/Scripps Health And Green Hospital — La Jolla, California, United States
• Va Long Beach Healthcare System — Long Beach, California, United States
• Univ. Of Southern Calif. /Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Dr. Felt Medical Office — Oakland, California, United States
• Stanford University — Stanford, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Florida Hospital Celebration Health — Celebration, Florida, United States
• Research Alliance, Inc. — Clearwater, Florida, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Pensacola Lung Group — Pensacola, Florida, United States
• Indian River Med. Ctr. — Vero Beach, Florida, United States
• Atlanta Institute For Medical Research, Inc — Atlanta, Georgia, United States
• Pulmonary & Critical Care Of Atlanta — Atlanta, Georgia, United States
• Idaho Falls Infectious Diseases, Pllc — Idaho Falls, Idaho, United States
• West Suburban Hospital — Oak Park, Illinois, United States
• Infectious Disease Of Indiana Psc — Carmel, Indiana, United States
• Cotton-O-Neil Clinical Research Center — Topeka, Kansas, United States
• Louisiana State University Health Sciences Center-Shreveport — Shreveport, Louisiana, United States
• University Of Alabama At Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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