Spots Global Cancer Trial Database for Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
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Trial Identification
Brief Title: Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
Official Title: A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy
Study ID: NCT03080883
Interventions
Study Description
Brief Summary: This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.
Detailed Description: PRIMARY OBJECTIVE: I. Any episode of major bleeding including fatal bleeding or clinically relevant non-major bleeding. SECONDARY OBJECTIVES: I. The proportion of patients who experienced at least one such bleeding event within 6 months of beginning treatment. II. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive lower dose apixaban orally (PO) twice daily (BID) for 365 days. GROUP II: Patients receive higher dose apixaban PO BID for 365 days. After completion of study treatment, patients are followed up for 30 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Cleveland Clinic-Weston, Weston, Florida, United States
Northwestern University, Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Saint Elizabeth Medical Center South, Edgewood, Kentucky, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New Hampshire Oncology Hematology PA-Hooksett, Hooksett, New Hampshire, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Solinsky Center for Cancer Care, Manchester, New Hampshire, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States
Dean Hematology and Oncology Clinic, Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Froedtert and the Medical College of Wisconsin LAPS, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Robert D McBane
Affiliation: Academic and Community Cancer Research United
Role: PRINCIPAL_INVESTIGATOR
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