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

NCT ID: NCT00457002

Last Updated: 2015-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6758 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-05-31

Brief Summary

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.

Conditions

Venous Thrombosis; Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Arm 2

While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

Interventions

Apixaban

Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Intervention Type: DRUG

Enoxaparin

Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

Intervention Type: DRUG

Other Intervention Names

BMS-562247

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

University Of Alabama At Birmingham Hospital

Birmingham, Alabama, United States

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

Johns Hopkins University School Of Medicine

Baltimore, Maryland, United States

Franklin Square Hospital

Baltimore, Maryland, United States

Henry Ford Hospital, Transplant Institute

Detriot, Michigan, United States

University Of Missouri-Columbia

Columbia, Missouri, United States

Mercury Street Medical Group, Pllc

Butte, Montana, United States

Creighton University Medical Center

Omaha, Nebraska, United States

Morristown Memorial Hospital

Mornstown, New Jersey, United States

North Shore University Hospital

Manhasset, New York, United States

Staten Island University Hospital

Staten Island, New York, United States

Mission Hospital, Inc

Asheville, North Carolina, United States

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

The Milton S Hershey Medical Center Of Penn. State Univ.

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Palmetto Nephrology Pa

Orangeburg, South Carolina, United States

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

Texas Health Presbyterian Dallas

Dallas, Texas, United States

Michael E. De Bakey Veteran Affairs Medical Center

Houston, Texas, United States

Sonterra Clinical Research

San Antonio, Texas, United States

Sonterra Clinical Research

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University Of Utah Medical Center

Salt Lake City, Utah, United States

Mcguire Va Medical Center

Richmond, Virginia, United States

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References

Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

Reference Type: DERIVED

PMID: 28762617 (View on PubMed)

Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

Reference Type: DERIVED

PMID: 28617144 (View on PubMed)

Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

Reference Type: DERIVED

PMID: 22863355 (View on PubMed)

Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

Reference Type: DERIVED

PMID: 22077144 (View on PubMed)

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CV185-036

Identifier Type: -

Identifier Source: org_study_id