A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Venous Thrombosis
Both
Venous Thrombosis
Trial Information
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Inclusion Criteria:
- Men and women ≥ 18 years of age
- Clinical diagnosis of DVT or PE
Exclusion Criteria:
- Contraindications for enoxaparin or warfarin
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Significantly impaired kidney or liver function
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Venous thromboembolic recurrence or death
Outcome Time Frame:
upon occurrence during study treatment
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Institutional Review Board
Study ID:
CV185-056
NCT ID:
NCT00643201
Start Date:
July 2008
Completion Date:
March 2013
Related Keywords:
- Venous Thrombosis
- Embolism
- Pulmonary Embolism
- Thrombosis
- Venous Thrombosis
- Venous Thromboembolism
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Bridgeport Hospital | Bridgeport, Connecticut 06610 |
| New York Medical College | Valhalla, New York 10595 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Greenville Hospital System | Greenville, South Carolina 29605 |
| Rex Healthcare | Raleigh, North Carolina 27607 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Anne Arundel Medical Center | Annapolis, Maryland 21401 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of California, Davis Medical Center | Sacramento, California |
| Oregon Health Science University | Portland, Oregon 97239 |
| Great Falls Clinic, LLP | Great Falls, Montana 59405 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
| Richmond University Medical Center | Staten Island, New York 10310-1699 |
| Veterans Affairs Medical Center | Kansas City, Missouri 64128 |
| University of Utah Medical Center | Salt Lake City, Utah 84132 |
| George Washington University Medical Faculty Associates | Washington, District of Columbia 20037 |
| Atlanta Institute For Medical Research, Inc | Decatur, Georgia 30030 |
| Internal Medical Associates Of Grand Island, P.C | Grand Island, Nebraska 68803 |
| Holston Medical Group | Bristol, Tennessee 37620 |
| Fort Smith Lung Center | Fort Smith, Arkansas 72901 |
| Research Alliance, Inc. | Clearwater, Florida 33756 |
| Infectious Disease Of Indiana Psc | Carmel, Indiana 46032 |
| University Of Missouri-Columbia | Columbia, Missouri 65212 |
| Mercury Street Medical Group, Pllc | Butte, Montana 59701 |
| Beaver Medical Group | Highland, California 92346 |
| Cleveland Clinic Florida | Weston, Florida 33331 |
| West Suburban Medical Center | Oak Park, Illinois 60302 |
| Alabama Clinical Therapeutics, Llc | Birmingham, Alabama 35235 |
| Horizon Research Group, Inc. | Mobile, Alabama 36608 |
| University Of California San Francisco-Fresno | Fresno, California 93701 |
| Chest Medicine & Critical Care Medical Gr. Inc. | San Diego, California 92123 |
| Harbor Ucla Medical Center | Torrance, California 90509 |
| New West Physicians | Golden, Colorado 80401 |
| Drogue Medical, Llc | Wheat Ridge, Colorado 80033 |
| Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med | New Haven, Connecticut 06510 |
| Bay Pines Va Healthcare Systems | Bay Pines, Florida 33744 |
| Daniel G. Lorch, Jr, Md, Cpi | Brandon, Florida 33511 |
| River City Clinical Research | Jacksonville, Florida 32207 |
| Pasadena Center For Medical Research | St. Petersburg, Florida 33707 |
| Tampa Clinical Research | Tampa, Florida 33624 |
| Office Of Michele S. Maholtz Md | Vero Beach, Florida 32960 |
| Atlanta Pulmonary Group | Atlanta, Georgia 30342 |
| Chatham Hospitalists | Savannah, Georgia 31405 |
| Gateway Cardiology. P.C | Jerseyville, Illinois 62052 |
| Heartland Vascular Medicine And Surgery | Windsor Heights, Iowa 50324 |
| Kentucky Lung Clinic | Hazard, Kentucky 41701 |
| Univ. Of Kentucky Dept. Of Surgery | Lexington, Kentucky 40536 |
| Research Integrity, Llc | Owensboro, Kentucky 42303 |
| Pen Bay Medical Center | Rockport, Maine 04856 |
| Medstar Research Health Institute | Baltimore, Maryland 21237 |
| R Adams Cowley Shock Trauma Center | Baltimore, Maryland 21201 |
| Mississippi Medical Research, Llc | Picayune, Mississippi 39466 |
| Mercy Hospital St.Louis | St. Louis, Missouri 63141 |
| Pulmonary & Critical Care Services, Pc | Albany, New York 12205 |
| Kaleida Health System | Buffalo, New York 14209 |
| Piedmont Healthcare/Research | Statesville, North Carolina 28625 |
| Wilmington Medical Research | Wilmington, North Carolina 28401 |
| Clinical Trials Of America, Inc. | Winston Salem, North Carolina 27103 |
| Altru Health System Clinic | Grand Forks, North Dakota 58201 |
| Huron Hospital | Cleveland, Ohio 44112 |
| Remington Davis Inc. | Columbus, Ohio 43215 |
| Palmetto Clinical Research | Summerville, South Carolina 29485 |
| Kore Cv Research | Jackson, Tennessee 38305 |
| Lake Washington Vascular, Pllc | Bellevue, Washington 98004 |
| Franciscan Research Center | Tacoma, Washington 98405 |
