Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

NCT ID: NCT00633893

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2711 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-08-31

Brief Summary

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Conditions

Venous Thrombosis

Study Design

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

Study Groups

1

2.5 mg

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Tablets, Oral, twice daily, 12 months

2

5.0 mg

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Tablets, Oral, twice daily, 12 months

3

0 mg

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets, Oral, twice daily, 12 months

Interventions

Apixaban

Tablets, Oral, twice daily, 12 months

Intervention Type: DRUG

Placebo

Tablets, Oral, twice daily, 12 months

Intervention Type: DRUG

Other Intervention Names

BMS-562247

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years of age;
• Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
• Anticoagulant treatment completed
• No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria

• Subjects with indications for long-term treatment with a vitamin K antagonist
• Active bleeding or high risk for serious bleeding
• Short life expectancy
• Uncontrolled high blood pressure
• Impaired kidney or liver function

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Alabama Clinical Therapeutics, Llc

Birmingham, Alabama, United States

Cardiovascular Consultants, Ltd.

Phoenix, Arizona, United States

Robert J. Bloomberg, Md, Pc

Tempe, Arizona, United States

Fort Smith Lung Center

Fort Smith, Arkansas, United States

Beaver Medical Group

Banning, California, United States

Scripps Clinic/Scripps Health And Green Hospital

La Jolla, California, United States

Healthcare Partners Medical Group

Los Angeles, California, United States

Mission Internal Medical Group

Mission Viejo, California, United States

Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

Palm Springs, California, United States

Indus Clinical Research Institute, Inc.

Pomona, California, United States

Kaiser Permanente Medical Center

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Harbor Ucla Medical Center

Torrance, California, United States

Progressive Clinical Research

Vista, California, United States

Rocky Mountain Internal Medicine

Aurora, Colorado, United States

New West Physicians

Golden, Colorado, United States

Alfieri Cardiology

Newark, Delaware, United States

Bay Pines Va Healthcare Systems

Bay Pines, Florida, United States

Research Alliance, Inc.

Clearwater, Florida, United States

St. Francis Sleep Allergy & Lung Institute

Clearwater, Florida, United States

Berma Research Group

Fort Lauderdale, Florida, United States

Healthworx

Hollywood, Florida, United States

Hematology Oncology Associates

Loxahatchee Groves, Florida, United States

South Miami Heart Center

Miami, Florida, United States

Physicians Regional Medical Group

Naples, Florida, United States

Richard A. Mclean M.D., P.A.

Plantation, Florida, United States

Tampa Clinical Research

Tampa, Florida, United States

Primary Care Of The Treasure Coast, Inc.

Vero Beach, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Vascular Surgical Associates, Pc

Austell, Georgia, United States

Atlanta Institute For Medical Research, Inc

Decatur, Georgia, United States

Gwinnett Biomedical Research

Lawrenceville, Georgia, United States

Boise Orthopedic Clinic

Boise, Idaho, United States

Saltzer Medical Group

Nampa, Idaho, United States

Infectious Disease Of Indiana Psc

Carmel, Indiana, United States

Office Of:Eugene C. Fletcher, Md

New Albany, Indiana, United States

Heartland Vascular Medicine And Surgery

Windsor Heights, Iowa, United States

Kentucky Lung Clinic

Hazard, Kentucky, United States

Owensboro Heart & Vascular

Owensboro, Kentucky, United States

Pen Bay Medical Center

Rockport, Maine, United States

Anne Arundel Health System Research Institute, Inc.

Annapolis, Maryland, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Veterans Affairs Medical Center

Kansas City, 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

Kaleida Health System

Buffalo, New York, United States

Goshen Medical Associates

Goshen, New York, United States

Sjh Cardiology Associates

Liverpool, New York, United States

Richmond University Medical Center

Staten Island, New York, United States

New York Medical College

Valhalla, New York, United States

Thomas L. Ortel, Md, Phd

Durham, North Carolina, United States

Valley Internal Medicine

Fayetteville, North Carolina, United States

Rex Healthcare

Raleigh, North Carolina, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Whiteville Medical Associates, P.A.

Whiteville, North Carolina, United States

Wilmington Medical Research

Wilmington, North Carolina, United States

Akron General Medical Center

Akron, Ohio, United States

Community Health Care, Inc.

Canal Fulton, Ohio, United States

Valley Medical Research

Centerville, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Remington Davis Inc.

Columbus, Ohio, United States

Jobst Vascular Center At The Toledo Hospital

Toledo, Ohio, United States

Cor Clinical Research, Llc

Oklahoma City, Oklahoma, United States

Pma Medical Specialists

Phoenixville, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Charleston Hematology Oncology Associates, Pa

Charleston, South Carolina, United States

Greenville Hospital System

Greenville, South Carolina, United States

Three Rivers Medical Associates, Pa

Irmo, South Carolina, United States

Clinical Research Authority, Llc

Murrells Inlet, South Carolina, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Holston Medical Group

Bristol, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Amarillo Heart Clinical Research Institute Inc.

Amarillo, Texas, United States

Corsicana Medical Research

Corsicana, Texas, United States

Ankur Doshi, Md

Houston, Texas, United States

Northwest Heart Center

Tomball, Texas, United States

Tanner Clinic

Layton, Utah, United States

University Of Utah Hospital

Salt Lake City, Utah, United States

University Of Virginia Health System

Charlottesville, Virginia, United States

Sentara York Clinical Research

Norfolk, Virginia, United States

Lake Washington Vascular, Pllc

Bellevue, Washington, United States

Franciscan Research Center

Tacoma, Washington, United States

Medical Assoicates Inc.

Menomonee Falls, Wisconsin, United States

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Hungary; Malaysia; Taiwan; Turkey (Türkiye); United States; Argentina; Australia; Austria; Brazil; Canada; Chile; Czechia; Denmark; France; Germany; Hong Kong; India; Israel; Italy; Mexico; Norway; Philippines; Poland; Portugal; Puerto Rico; Romania; Russia; Singapore; South Africa; South Korea; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35570249 (View on PubMed)

Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

Reference Type: DERIVED

PMID: 26446706 (View on PubMed)

Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

Reference Type: DERIVED

PMID: 23216615 (View on PubMed)

Related Links

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

Investigator Inquiry form

Other Identifiers

EUDRACT: 2007-004953-27

Identifier Type: -

Identifier Source: secondary_id

CV185-057

Identifier Type: -

Identifier Source: org_study_id